Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT00652834
Status:
COMPLETED
Last Update Posted:
2016-03-04
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bunnapradist@mednet.ucla.edu', 'phone': '310-794-8516', 'title': 'Dr. Bunnapradist', 'organization': 'UCLA Kidney Transplant Research Program'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We did not enroll asymptomatic patients and in the extension of the trial the number of patients re-examined were few and the data obtained from them are not enough to provide definitive information.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Kidney Transplant Recipients With GI Symptoms', 'description': 'If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.\n\nSmall bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.\n\nSmall bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kidney Transplant Recipients With GI Symptoms', 'description': 'If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.\n\nSmall bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.\n\nSmall bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '2.99', 'groupId': 'OG000', 'lowerLimit': '2.18', 'upperLimit': '3.80'}]}]}, {'title': 'day 30', 'categories': [{'measurements': [{'value': '2.19', 'groupId': 'OG000', 'lowerLimit': '1.39', 'upperLimit': '2.99'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'pValueComment': 'The p value is only for GSRS score comparison only.', 'estimateComment': 'The GSRS range is 1-7', 'groupDescription': "The results of the initial SBCE exams were evaluated by a visually challenged GI specialist who gave us a descriptive report. By the end of the study, we submitted the final reports to the same specialist and asked his impression on the significant changes observed in patients' exams for each GI segment (stomach and small bowel).\n\nThere were no comparison groups. Each patient is their own control. Given that this is a pilot study there is no power calculation.", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'one month', 'description': 'The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.\n\nA higher GSRS indicate worse symptoms and a difference between D30 and last SBCE scores greater or equal to 0.3 can be considered as a clinically significant improvement in the symptoms.', 'unitOfMeasure': 'GSRS score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Kidney Transplant Recipients With GI Symptoms', 'description': 'Small bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.\n\nSmall bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '3 subjects withdrew after completing baseline questionnaire. 2 did not complete 30-day visit.', 'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Kidney Transplant Clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Kidney Transplant Recipients With GI Symptoms', 'description': 'If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.\n\nSmall bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2 and Day 30.\n\nSmall bowel capsule endoscopy (SBCE): SBCE will be performed at Day 2.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '11.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'of 23 participants, 18 participants completed the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2008-04-01', 'resultsFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-05', 'studyFirstPostDateStruct': {'date': '2008-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score', 'timeFrame': 'one month', 'description': 'The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.\n\nA higher GSRS indicate worse symptoms and a difference between D30 and last SBCE scores greater or equal to 0.3 can be considered as a clinically significant improvement in the symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Renal transplant recipients', 'Gastrointestinal findings in small bowel capsule endoscopy', 'Mycophenolic acid', 'Mycophenolate Mofetil', 'Mycophenolate Sodium'], 'conditions': ['Gastrointestinal Lesions', 'Signs and Symptoms, Digestive']}, 'referencesModule': {'references': [{'pmid': '8588243', 'type': 'BACKGROUND', 'citation': 'Shaw LM, Sollinger HW, Halloran P, Morris RE, Yatscoff RW, Ransom J, Tsina I, Keown P, Holt DW, Lieberman R, et al. Mycophenolate mofetil: a report of the consensus panel. Ther Drug Monit. 1995 Dec;17(6):690-9. doi: 10.1097/00007691-199512000-00025. No abstract available.'}, {'pmid': '10868649', 'type': 'BACKGROUND', 'citation': 'Ojo AO, Meier-Kriesche HU, Hanson JA, Leichtman AB, Cibrik D, Magee JC, Wolfe RA, Agodoa LY, Kaplan B. Mycophenolate mofetil reduces late renal allograft loss independent of acute rejection. Transplantation. 2000 Jun 15;69(11):2405-9. doi: 10.1097/00007890-200006150-00033.'}, {'pmid': '12492713', 'type': 'BACKGROUND', 'citation': 'Meier-Kriesche HU, Steffen BJ, Hochberg AM, Gordon RD, Liebman MN, Morris JA, Kaplan B. Long-term use of mycophenolate mofetil is associated with a reduction in the incidence and risk of late rejection. Am J Transplant. 2003 Jan;3(1):68-73. doi: 10.1034/j.1600-6143.2003.30112.x.'}, {'pmid': '11522119', 'type': 'BACKGROUND', 'citation': 'Behrend M. Adverse gastrointestinal effects of mycophenolate mofetil: aetiology, incidence and management. Drug Saf. 2001;24(9):645-63. doi: 10.2165/00002018-200124090-00002.'}, {'pmid': '14974944', 'type': 'BACKGROUND', 'citation': 'Salvadori M, Holzer H, de Mattos A, Sollinger H, Arns W, Oppenheimer F, Maca J, Hall M; ERL B301 Study Groups. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am J Transplant. 2004 Feb;4(2):231-6. doi: 10.1046/j.1600-6143.2003.00337.x.'}, {'pmid': '9110389', 'type': 'BACKGROUND', 'citation': 'Dimenas E, Carlsson G, Glise H, Israelsson B, Wiklund I. Relevance of norm values as part of the documentation of quality of life instruments for use in upper gastrointestinal disease. Scand J Gastroenterol Suppl. 1996;221:8-13. doi: 10.3109/00365529609095544.'}, {'pmid': '15848552', 'type': 'BACKGROUND', 'citation': 'Kleinman L, Faull R, Walker R, Ramesh Prasad GV, Ambuehl P, Bahner U. Gastrointestinal-specific patient-reported outcome instruments differentiate between renal transplant patients with or without GI complications. Transplant Proc. 2005 Mar;37(2):846-9. doi: 10.1016/j.transproceed.2004.12.106.'}, {'pmid': '25196230', 'type': 'RESULT', 'citation': 'Bunnapradist S, Sampaio MS, Wilkinson AH, Pham PT, Huang E, Kuo HT, Anastasi B, Danovitch GM, Lo SK. Changes in the small bowel of symptomatic kidney transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium. Am J Nephrol. 2014;40(2):184-90. doi: 10.1159/000365360. Epub 2014 Sep 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn more about symptoms and gastrointestinal lesions associated with taking myfortic® by switching patients to a delayed release formulation that is developed to alleviate GI symptoms. A comparison of the frequency and severity of GI symptoms observed in patients treated with MMF (cellcept®) after conversion to myfortic® will be measured by using a self-assessed questionnaire called Gastrointestinal Symptom Rating Scale (GSRS). To prove the incidence and improvement of GI lesions in patients treated with MMF (cellcept®) after conversion to myfortic® will be measured by using Small Bowel Capsule Endoscopy (SBCE).', 'detailedDescription': 'Myfortic® recently introduced to the market has shown to be similar to MMF in how effectively it works and how well it is tolerated. Both drugs have the same active ingredient, but they are different in the way that they deliver them to the body. Myfortic® is an advanced, enteric coated formulation of mycophenolate sodium (EC-MPS) that delays the release of the active ingredient, MPA. MPA has more potent effects on the lymphocytes than other cells. This makes for improved GI tolerability of the MPA therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients between 18 and 75 years of age.\n* Recipients of first or second cadaveric, living unrelated or living related kidney transplant.\n* Recipients who are at least 4 weeks post renal transplantation with stable renal function.\n* Patients who have used MMF at least 10 days and are currently receiving MMF. (up to 3g/day dosage allowed)\n* Patients with at least one moderate or severe upper or lower GI complaints.\n* Patients' immunosuppressive regimen other than steroids as well as medication for treatment of GI symptoms must be unchanged for at least 1 week prior to study start.\n* Females of childbearing potential must have a negative pregnancy test prior to the inclusion period. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication.\n* Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.\n\nExclusion Criteria:\n\n* Multi-organ transplant patients or previous transplant with any other organ different from kidney.\n* The presence of a severe GI disorder. History of a significant GI disorder prior to transplant that has remained unchanged since transplant and/or the introduction of MMF will exclude patient.\n* Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MMF.\n* Modification of GI medication or MMF dose within last 1 week.\n* Evidence of graft rejection, treatment of acute rejection, or unstable renal function within 4 weeks prior to the Baseline visit.\n* Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.\n* Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.\n* Pregnant or nursing women.\n* Patients with thrombocytopenia (\\<75,000/mm3), with an absolute neutrophil count of \\<1,500/mm3 and/or leukocytopenia (\\<3,500/mm3), and/or hemoglobin \\<9.0 g/dL prior to enrollment.\n* Presence of clinically significant pyrexia and/or infection requiring continued therapy.\n* Evidence of severe liver disease \\[incl. abnormal liver profile i.e. AST, ALT or total bilirubin = 3 times the upper limit of normal\\].\n* Patients who have any anatomical GI tract defects which have risk of capsule getting stuck such as tumor or previous abdominal surgery.\n* Abnormal physical or laboratory findings of clinical significance within 2 weeks of inclusion which would interfere with the objectives of the study.\n* Patients with symptoms of significant illness or evidence of current drug and/or alcohol abuse.\n* Inability to self-administer the GSRS \\& OTE questionnaire.\n* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.\n* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures."}, 'identificationModule': {'nctId': 'NCT00652834', 'briefTitle': 'Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Gastrointestinal Mucosal Findings in Patients Receiving Mycophenolic Acid (MPA) as Demonstrated by Small Bowel Capsule Endoscopy (SBCE)', 'orgStudyIdInfo': {'id': '11-001911'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'kidney recipients with GI symptoms', 'description': 'This was a four-week study designed to investigate GI mucosal lesions by SBCE in kidney transplant recipients who were using MMF, and to examine the changes in clinical symptoms and intestinal mucosa lesions 30 days after switching over from MMF to EC-MPS. The patient was switched from MMF to EC-MPS (Myfortic) on the equimola basis.', 'interventionNames': ['Procedure: Small bowel capsule endoscopy (SBCE)', 'Drug: myfortic']}], 'interventions': [{'name': 'Small bowel capsule endoscopy (SBCE)', 'type': 'PROCEDURE', 'otherNames': ['PillCamEso'], 'description': 'SBCE will be performed at Day 2 and Day 30.', 'armGroupLabels': ['kidney recipients with GI symptoms']}, {'name': 'myfortic', 'type': 'DRUG', 'otherNames': ['EC-MPS'], 'description': 'switching from mycophenolate mofetil to mycophenolic acid on equimolar basis', 'armGroupLabels': ['kidney recipients with GI symptoms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'suphamai bunnapradist, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Suphamai Bunnapradist', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}