Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT00758602
Status:
COMPLETED
Last Update Posted:
2014-08-04
First Post:
2008-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Taiwan', 'United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffman-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were recorded from study start to 1 month after treatment completion. Treatment related serious AEs (SAEs) were reported no matter how long after the last treatment dose was administered, even though the study had been terminated.', 'description': 'All randomized participants were included in the safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.', 'otherNumAtRisk': 104, 'otherNumAffected': 33, 'seriousNumAtRisk': 104, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.', 'otherNumAtRisk': 106, 'otherNumAffected': 37, 'seriousNumAtRisk': 106, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Alanine transaminase (ALT) increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell (WBC) count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Serum creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate transamininase (AST) increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperlipemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'New-onset diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercholesterolemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Others - not specified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transplanted renal rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cytomegalovirus (CMV) disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'OG001', 'title': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.82', 'spread': '1.974', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '2.000', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0813', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6581', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '1.40', 'pValueComment': 'p-value, least squares (LS) mean difference, and 95% confidence interval (CI) based on analysis of covariance (ANCOVA) model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (\\~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (\\>)50% cell infiltration); interstitial fibrosis (0=none, 1=\\~25% interstitial affected, 2=26-50% interstitial affected, and 3=\\>50% interstitial affected); tubular atrophy (0=none, 1=\\~15% proximal tubular atrophy \\[PTA\\], 2=16-30% PTA, and 3=\\>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis \\[NGS\\] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=\\>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=\\~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=\\>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (\\<)25% remaining artery/small artery membrane \\[RA/SAM\\], 2=EP to 26-50% \\[RA/SAM\\], and 3=\\>50% \\[RA/SAM\\]). CADI score was the sum of the 6 histological findings.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; only participants with biopsy confirmed CADI assessment 12 months post-transplantation were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Glomerular Filtration Rate (GFR) at Month 12 After Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'OG001', 'title': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.08', 'spread': '18.250', 'groupId': 'OG000'}, {'value': '80.12', 'spread': '18.362', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7949', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5977', 'ciLowerLimit': '-13.77', 'ciUpperLimit': '10.58', 'pValueComment': 'p-value, LS mean difference, and 95% CI based on ANCOVA model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance \\[milliliters per minute (mL/min)\\] = \\[(140 minus age) multiplied by (\\*) (body weight in kg) divided by \\[72 \\* serum creatinine mg per deciliter (mg/dL)\\]. For females, creatinine clearance (mL/min) = 0.85 \\* \\[(140 minus age) \\* (body weight in kg)\\] divided by \\[72 \\* serum creatinine (mg/dL)\\].', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; only participants with assessable parameters for the calculation of GFR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'OG001', 'title': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}], 'classes': [{'title': 'Acute rejection, 6 months post-transplant', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Acute rejection, 12 months post-transplant', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Graft loss, 6 months post-transplant', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Graft loss, 12 months post-transplant', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Death, 6 months post-transplant', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Death, 12 months post-transplant', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6812', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Acute rejection, 6 months post-transplant', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6812', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Acute rejection, 12 months post-transplant', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Death, 12 months post-transplant', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Months 6 and 12', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time to First Acute Rejection Post-Transplant - Number of Participants With an Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'OG001', 'title': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'BL, Weeks 2, 4, 13, 26, 39, and 52', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time to First Acute Rejection Post-Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'OG001', 'title': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '67'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '95'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'BL, Weeks 2, 4, 13, 26, 39, and 52', 'description': 'The median time, in days, between randomization and acute rejection.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Failure at 12 Months Post-Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'OG001', 'title': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '6.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4586', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Participant and Graft Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'OG001', 'title': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}], 'classes': [{'title': '6 months post-transplant', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': '12 months post-transplant', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '99.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Months 6 and 12', 'description': 'The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Serum Creatinine (Micromoles Per Liter [µmol/L])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'OG001', 'title': 'MMFl, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}], 'classes': [{'title': 'Baseline (n=95,96)', 'categories': [{'measurements': [{'value': '662.93', 'spread': '351.913', 'groupId': 'OG000'}, {'value': '639.70', 'spread': '287.044', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=101,102)', 'categories': [{'measurements': [{'value': '154.57', 'spread': '151.374', 'groupId': 'OG000'}, {'value': '115.71', 'spread': '52.648', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=99,98)', 'categories': [{'measurements': [{'value': '118.47', 'spread': '76.134', 'groupId': 'OG000'}, {'value': '107.08', 'spread': '32.668', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=88,91)', 'categories': [{'measurements': [{'value': '97.52', 'spread': '24.947', 'groupId': 'OG000'}, {'value': '100.10', 'spread': '25.345', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=84,83)', 'categories': [{'measurements': [{'value': '105.70', 'spread': '45.403', 'groupId': 'OG000'}, {'value': '97.51', 'spread': '21.997', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=83,77)', 'categories': [{'measurements': [{'value': '102.22', 'spread': '38.035', 'groupId': 'OG000'}, {'value': '95.16', 'spread': '20.877', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=86,82)', 'categories': [{'measurements': [{'value': '103.10', 'spread': '48.251', 'groupId': 'OG000'}, {'value': '94.19', 'spread': '21.964', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL, Weeks 2, 4, 13, 26, 39, and 52', 'description': 'The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': 'Glomerular Filtration Rate (GFR) (mL/Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'OG001', 'title': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}], 'classes': [{'title': 'Baseline (n=95,96)', 'categories': [{'measurements': [{'value': '14.37', 'spread': '8.080', 'groupId': 'OG000'}, {'value': '15.41', 'spread': '13.759', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=101,102)', 'categories': [{'measurements': [{'value': '67.95', 'spread': '30.140', 'groupId': 'OG000'}, {'value': '71.02', 'spread': '22.177', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=99,98)', 'categories': [{'measurements': [{'value': '71.77', 'spread': '23.578', 'groupId': 'OG000'}, {'value': '72.87', 'spread': '19.934', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 (n=88,91)', 'categories': [{'measurements': [{'value': '78.13', 'spread': '18.686', 'groupId': 'OG000'}, {'value': '75.71', 'spread': '17.906', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=84,83)', 'categories': [{'measurements': [{'value': '75.92', 'spread': '21.046', 'groupId': 'OG000'}, {'value': '76.77', 'spread': '17.536', 'groupId': 'OG001'}]}]}, {'title': 'Week 39 (n=83,77)', 'categories': [{'measurements': [{'value': '77.34', 'spread': '19.046', 'groupId': 'OG000'}, {'value': '78.00', 'spread': '16.036', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=86,82)', 'categories': [{'measurements': [{'value': '77.08', 'spread': '18.250', 'groupId': 'OG000'}, {'value': '80.12', 'spread': '18.362', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'BL, Weeks 2, 4, 13, 26, 39, and 52', 'description': 'The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed for the specified parameter at a given visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mycophenolate Mofetil (MMF), Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 gram (g) orally (PO), twice daily (BID) from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'FG001', 'title': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Reason not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator). Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 10-12 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 8-10 ng/mL in Month 3 and continued through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'BG001', 'title': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF capsules, 0.75-1 g PO, BID from Day 0 through Month 12 (maximum dose administered was 1.5 g BID, at discretion of investigator. Participants also received tacrolimus PO, BID, dosed to reach a target trough level of 8-10 ng/mL from Day 0 through Month 2; the dose was adjusted reach a target trough level of 3-7 ng/mL in Month 3 and adjusted to achieve a target trough level of 3-5 ng/mL thereafter, through Month 12. Participants also received intraoperative and maintenance corticosteroids per center practice.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '11.05', 'groupId': 'BG000'}, {'value': '39.6', 'spread': '10.16', 'groupId': 'BG001'}, {'value': '38.8', 'spread': '10.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population: all randomized patients who received at least one dose ofthe treatment-group specific medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-08', 'studyFirstSubmitDate': '2008-09-24', 'resultsFirstSubmitDate': '2014-07-08', 'studyFirstSubmitQcDate': '2008-09-24', 'lastUpdatePostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-08', 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation', 'timeFrame': 'Month 12', 'description': 'CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (\\~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (\\>)50% cell infiltration); interstitial fibrosis (0=none, 1=\\~25% interstitial affected, 2=26-50% interstitial affected, and 3=\\>50% interstitial affected); tubular atrophy (0=none, 1=\\~15% proximal tubular atrophy \\[PTA\\], 2=16-30% PTA, and 3=\\>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis \\[NGS\\] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=\\>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=\\~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=\\>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (\\<)25% remaining artery/small artery membrane \\[RA/SAM\\], 2=EP to 26-50% \\[RA/SAM\\], and 3=\\>50% \\[RA/SAM\\]). CADI score was the sum of the 6 histological findings.'}, {'measure': 'Glomerular Filtration Rate (GFR) at Month 12 After Transplantation', 'timeFrame': 'Month 12', 'description': 'GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance \\[milliliters per minute (mL/min)\\] = \\[(140 minus age) multiplied by (\\*) (body weight in kg) divided by \\[72 \\* serum creatinine mg per deciliter (mg/dL)\\]. For females, creatinine clearance (mL/min) = 0.85 \\* \\[(140 minus age) \\* (body weight in kg)\\] divided by \\[72 \\* serum creatinine (mg/dL)\\].'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant', 'timeFrame': 'Months 6 and 12'}, {'measure': 'Time to First Acute Rejection Post-Transplant - Number of Participants With an Event', 'timeFrame': 'BL, Weeks 2, 4, 13, 26, 39, and 52'}, {'measure': 'Time to First Acute Rejection Post-Transplant', 'timeFrame': 'BL, Weeks 2, 4, 13, 26, 39, and 52', 'description': 'The median time, in days, between randomization and acute rejection.'}, {'measure': 'Percentage of Participants With Treatment Failure at 12 Months Post-Transplant', 'timeFrame': 'Month 12', 'description': 'Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.'}, {'measure': 'Participant and Graft Survival', 'timeFrame': 'Months 6 and 12', 'description': 'The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.'}, {'measure': 'Serum Creatinine (Micromoles Per Liter [µmol/L])', 'timeFrame': 'BL, Weeks 2, 4, 13, 26, 39, and 52', 'description': 'The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.'}, {'measure': 'Glomerular Filtration Rate (GFR) (mL/Min)', 'timeFrame': 'BL, Weeks 2, 4, 13, 26, 39, and 52', 'description': 'The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.'}]}, 'conditionsModule': {'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid + tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or 2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3 followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\<=75 years of age;\n* single organ recipients of renal allograft;\n* negative pregnancy test for women of childbearing potential; reliable contraception must be used before starting drug therapy, until 6 weeks after the last dose of study medication.\n\nExclusion Criteria:\n\n* severe gastrointestinal disease which may influence the absorption of oral drug therapy;\n* severe infection, HIV or active hepatitis;\n* active gastric ulcers;\n* malignancy other than cured skin cancer;\n* severe anemia, leucopenia or thrombocytopenia.'}, 'identificationModule': {'nctId': 'NCT00758602', 'briefTitle': 'A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Open Label Study Comparing the Effect of CellCept Combined With Low Dose Versus Standard Dose Tacrolimus, and Corticosteroids, on Kidney Function in Renal Transplantation Patients', 'orgStudyIdInfo': {'id': 'ML21740'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MMF, Standard Dose Tacrolimus', 'description': 'Participants received mycophenolate mofetil (MMF) 0.75 to (-) 1 gram (g), orally (PO), twice daily (BID) from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 milligrams per kilogram (mg/kg), PO, BID to reach a target trough dose of 8-10 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice.', 'interventionNames': ['Drug: mycophenolate mofetil', 'Drug: tacrolimus, standard dose', 'Drug: corticosteroids']}, {'type': 'EXPERIMENTAL', 'label': 'MMF, Low Dose Tacrolimus', 'description': 'Participants received MMF 0.75-1 g, PO, BID from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 mg/kg, PO, BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to 0.05-0.08 mg/kg, PO, BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice.', 'interventionNames': ['Drug: mycophenolate mofetil', 'Drug: tacrolimus, low dose', 'Drug: corticosteroids']}], 'interventions': [{'name': 'mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['CellCept'], 'description': '0.75-1 g PO BID from Day 0 through Month 12', 'armGroupLabels': ['MMF, Low Dose Tacrolimus', 'MMF, Standard Dose Tacrolimus']}, {'name': 'tacrolimus, standard dose', 'type': 'DRUG', 'description': 'Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12.', 'armGroupLabels': ['MMF, Standard Dose Tacrolimus']}, {'name': 'tacrolimus, low dose', 'type': 'DRUG', 'description': 'Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8 to 10 ng/mL from Day 0 through Month 3; 0.05-0.08 mg/kg PO BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12.', 'armGroupLabels': ['MMF, Low Dose Tacrolimus']}, {'name': 'corticosteroids', 'type': 'DRUG', 'description': "According to center's practice", 'armGroupLabels': ['MMF, Low Dose Tacrolimus', 'MMF, Standard Dose Tacrolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350025', 'city': 'Fuzhou', 'country': 'China', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510080', 'city': 'Guangzhou', 'country': 'China', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '210008', 'city': 'Nanjing', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310003', 'city': 'Zhejiang', 'country': 'China', 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}