Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-29 @ 6:19 PM
Study NCT ID:
NCT01672957
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2012-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D007165', 'term': 'Immunosuppression Therapy'}], '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': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, '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': 'From Baseline up to Month 12', 'description': 'Safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.", 'otherNumAtRisk': 128, 'otherNumAffected': 51, 'seriousNumAtRisk': 128, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 24}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Kidney transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 14}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Complications of transplanted kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Perirenal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ureteric anastomosis complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyelocaliectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ureteral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Varicocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiration abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Creatinine Clearance at 1 Month After Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen."}], 'classes': [{'categories': [{'measurements': [{'value': '65.82', 'spread': '18.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1', 'description': 'Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.'}, {'type': 'PRIMARY', 'title': 'Creatinine Clearance at Month 6 After Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen."}], 'classes': [{'categories': [{'measurements': [{'value': '73.38', 'spread': '19.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.'}, {'type': 'PRIMARY', 'title': 'Creatinine Clearance at Month 12 After Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen."}], 'classes': [{'categories': [{'measurements': [{'value': '69.69', 'spread': '21.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.'}, {'type': 'PRIMARY', 'title': 'Glomerular Filtration Rate (GFR) at Month 1 After Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen."}], 'classes': [{'categories': [{'measurements': [{'value': '53.54', 'spread': '33.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1', 'description': 'GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (\\>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (\\<) 15 mL/min indicates kidney failure.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.'}, {'type': 'PRIMARY', 'title': 'GFR at Month 6 After Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen."}], 'classes': [{'categories': [{'measurements': [{'value': '56.78', 'spread': '15.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \\> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \\< 15 mL/min indicates kidney failure.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.'}, {'type': 'PRIMARY', 'title': 'GFR at Month 12 After Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen."}], 'classes': [{'categories': [{'measurements': [{'value': '58.03', 'spread': '16.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \\> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \\< 15 mL/min indicates kidney failure.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.'}, {'type': 'SECONDARY', 'title': 'Mean Dose of Mycophenolate Mofetil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen."}], 'classes': [{'title': 'Baseline (n=121)', 'categories': [{'measurements': [{'value': '2033.06', 'spread': '357.86', 'groupId': 'OG000'}]}]}, {'title': 'Month 1 (n=119)', 'categories': [{'measurements': [{'value': '1718.49', 'spread': '543.21', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=88)', 'categories': [{'measurements': [{'value': '1457.39', 'spread': '754.51', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=69)', 'categories': [{'measurements': [{'value': '1539.86', 'spread': '669.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 1, 6, and 12', 'unitOfMeasure': 'milligrams (mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen."}], 'classes': [{'title': '1 Other agent: at baseline (n=121)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': '1 Other agent: at Month 1 (n=119)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': '1 Other agent: at Month 6 (n=86)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': '1 Other agent: at Month 12 (n=69)', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}]}]}, {'title': '2 Other agents: at baseline (n=121)', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': '2 Other agents: at Month 1 (n=119)', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000'}]}]}, {'title': '2 Other agents: at Month 6 (n=86)', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}]}]}, {'title': '2 Other agents: at Month 12 (n=69)', 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000'}]}]}, {'title': '3 Other agents: at baseline (n=121)', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}]}]}, {'title': '3 Other agents: at Month 1 (n=119)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3 Other agents: at Month 6 (n=86)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3 Other agents: at Month 12 (n=69)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Months 1, 6, and 12', 'description': 'Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Acute Rejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen."}], 'classes': [{'title': 'Baseline to Month 1 (n=127)', 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000'}]}]}, {'title': 'Months 2 to 6 (n=124)', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Months 7 to 12 (n=111)', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 1, Months 2 to 6, Months 7 to 12', 'description': 'Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy (safety population=128). Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Graft Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen."}], 'classes': [{'title': 'Month 1 (n=127)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=123)', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 12 (n=111)', 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 1, 6, and 12', 'description': 'Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for \\>8 weeks), re-transplant or death during the first 12 months after transplantation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil (CellCept), were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). The study protocol did not specify any treatment regimen."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}]}, {'type': 'Intent-to-treat (ITT) Population', 'achievements': [{'comment': 'All enrolled participants who had no major protocol violation.', 'groupId': 'FG000', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'ICF Signed After Transplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'If Informed Consent Form (ICF) was signed after the transplantation, it was considered as a major protocol violation and reported separately from protocol violation in Participant Flow.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Renal Transplant Participants', 'description': "Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.60', 'spread': '13.24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy and had no major protocol violation.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-16', 'studyFirstSubmitDate': '2012-08-22', 'resultsFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2012-08-22', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-16', 'studyFirstPostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creatinine Clearance at 1 Month After Transplantation', 'timeFrame': 'Month 1', 'description': 'Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.'}, {'measure': 'Creatinine Clearance at Month 6 After Transplantation', 'timeFrame': 'Month 6', 'description': 'Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.'}, {'measure': 'Creatinine Clearance at Month 12 After Transplantation', 'timeFrame': 'Month 12', 'description': 'Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.'}, {'measure': 'Glomerular Filtration Rate (GFR) at Month 1 After Transplantation', 'timeFrame': 'Month 1', 'description': 'GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (\\>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (\\<) 15 mL/min indicates kidney failure.'}, {'measure': 'GFR at Month 6 After Transplantation', 'timeFrame': 'Month 6', 'description': 'GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \\> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \\< 15 mL/min indicates kidney failure.'}, {'measure': 'GFR at Month 12 After Transplantation', 'timeFrame': 'Month 12', 'description': 'GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \\> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \\< 15 mL/min indicates kidney failure.'}], 'secondaryOutcomes': [{'measure': 'Mean Dose of Mycophenolate Mofetil', 'timeFrame': 'Baseline, Months 1, 6, and 12'}, {'measure': 'Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil', 'timeFrame': 'Baseline, Months 1, 6, and 12', 'description': 'Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.'}, {'measure': 'Percentage of Participants With Acute Rejection', 'timeFrame': 'Baseline to Month 1, Months 2 to 6, Months 7 to 12', 'description': 'Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.'}, {'measure': 'Percentage of Participants With Graft Survival', 'timeFrame': 'Months 1, 6, and 12', 'description': 'Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for \\>8 weeks), re-transplant or death during the first 12 months after transplantation.'}]}, 'conditionsModule': {'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'This observational study will evaluate renal function in participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil (CellCept). Eligible participants will be followed for 12 months following transplantation.', 'detailedDescription': "The participant sampling method used in the Orange study was consecutive sampling, a non-probability sampling method where each participant meeting the study's inclusion and exclusion criteria is selected and enrolled in the study until the pre-set sample size is achieved.\n\nThus, in the Orange study de novo kidney transplanted participants, who were on mycophenolate mofetil immunosuppressive combination therapy in routine clinical practice, were selected in a consecutive manner (a non-probability sampling method) if they met the inclusion/exclusion criteria until 128 participants were recruited to the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Renal allograft transplant participants initiated on combined immunosuppressive treatment containing mycophenolate mofetil', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil in accordance with the indication provided by the SmPC of mycophenolate mofetil\n* Date of study enrollment is the date of kidney transplantation\n\nExclusion Criteria:\n\n* Contraindication included in the SmPC for capecitabine (Xeloda) prevailed, like: Hypersensitivity to active ingredient or any of the excipients of the product; Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT01672957', 'acronym': 'ORANGE', 'briefTitle': 'An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Non-interventional Clinical Study With Target of Kidney Function Follow-up in Routine Clinical Practice on De Novo Kidney Transplant Recipients Who Are on CellCept Immunosuppressive Combination Therapy in Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'ML27844'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Renal Transplant Participants', 'description': "Renal transplant participants who will be subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, will be followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurs first. The choice of treatment will be made prior to enrolment by the treating physician. The treatment will be administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC).", 'interventionNames': ['Drug: Mycophenolate Mofetil', 'Drug: Immunosuppressive Therapy']}], 'interventions': [{'name': 'Mycophenolate Mofetil', 'type': 'DRUG', 'otherNames': ['CellCept'], 'description': 'Protocol does not specify any regimen for treatment. The choice of treatment will be made prior to enrollment by the treating physician.', 'armGroupLabels': ['Renal Transplant Participants']}, {'name': 'Immunosuppressive Therapy', 'type': 'DRUG', 'description': 'Protocol does not specify any particular immunosuppressive drug and regimen for treatment. The choice of immunosuppressive therapy will be made prior to enrollment by the treating physician.', 'armGroupLabels': ['Renal Transplant Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1082', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '7624', 'city': 'Pécs', 'country': 'Hungary', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}