Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT02991768
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2016-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients
Sponsor:
Organization:
Raw JSON
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Complete remission (CR) is defined as a mean of \\<3 stools/day and a mean of \\<1 watery stool per day without use of anti-diarrheal drugs.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. Physician left the institution and study was terminated.'}, {'type': 'SECONDARY', 'title': 'Change in Gastrointestinal Symptom Rating Scale (GSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entocort EC', 'description': 'Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.\n\nEntocort: A corticosteroid that decreases levels of inflammatory cytokines.'}], 'timeFrame': 'Change from Baseline to Week 8', 'description': 'GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. Physician left the institution and study was terminated.'}, {'type': 'SECONDARY', 'title': 'Change in Gastrointestinal Symptom Rating Scale (GSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entocort EC', 'description': 'Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.\n\nEntocort: A corticosteroid that decreases levels of inflammatory cytokines.'}], 'timeFrame': 'Change from Baseline to Week 16', 'description': 'GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. Physician left the institution and study was terminated.'}, {'type': 'SECONDARY', 'title': 'Change in Gastrointestinal Quality of Life Index (GIQLI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entocort EC', 'description': 'Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.\n\nEntocort: A corticosteroid that decreases levels of inflammatory cytokines.'}], 'timeFrame': 'Change from Baseline to Week 8', 'description': 'The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. Physician left the institution and study was terminated.'}, {'type': 'SECONDARY', 'title': 'Change in Gastrointestinal Quality of Life Index (GIQLI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entocort EC', 'description': 'Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.\n\nEntocort: A corticosteroid that decreases levels of inflammatory cytokines.'}], 'timeFrame': 'Change from Baseline to Week 16', 'description': 'The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. Physician left the institution and study was terminated.'}, {'type': 'SECONDARY', 'title': 'MPA Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entocort EC', 'description': 'Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.\n\nEntocort: A corticosteroid that decreases levels of inflammatory cytokines.'}], 'timeFrame': 'Change from Baseline to Week 8', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. Physician left the institution and study was terminated.'}, {'type': 'SECONDARY', 'title': 'MPA Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entocort EC', 'description': 'Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.\n\nEntocort: A corticosteroid that decreases levels of inflammatory cytokines.'}], 'timeFrame': 'Change from Baseline to Week 16', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. Physician left the institution and study was terminated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Entocort EC', 'description': 'Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.\n\nEntocort: A corticosteroid that decreases levels of inflammatory cytokines.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entocort EC', 'description': 'Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.\n\nEntocort: A corticosteroid that decreases levels of inflammatory cytokines.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '70'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-26', 'size': 346522, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-27T10:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Enrollment not continued', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2016-11-21', 'resultsFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2016-12-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-27', 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Remission of Diarrhea', 'timeFrame': 'Week 8', 'description': 'Measured using symptom diary. Complete remission (CR) is defined as a mean of \\<3 stools/day and a mean of \\<1 watery stool per day without use of anti-diarrheal drugs.'}], 'secondaryOutcomes': [{'measure': 'Change in Gastrointestinal Symptom Rating Scale (GSRS)', 'timeFrame': 'Change from Baseline to Week 8', 'description': 'GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).'}, {'measure': 'Change in Gastrointestinal Symptom Rating Scale (GSRS)', 'timeFrame': 'Change from Baseline to Week 16', 'description': 'GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).'}, {'measure': 'Change in Gastrointestinal Quality of Life Index (GIQLI)', 'timeFrame': 'Change from Baseline to Week 8', 'description': 'The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction.'}, {'measure': 'Change in Gastrointestinal Quality of Life Index (GIQLI)', 'timeFrame': 'Change from Baseline to Week 16', 'description': 'The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 subscales (GI symptoms, emotional status, physical functions, social functions, and stress of medical treatment), producing a total score of the 36 items. Lower scores represent more dysfunction.'}, {'measure': 'MPA Dose', 'timeFrame': 'Change from Baseline to Week 8'}, {'measure': 'MPA Dose', 'timeFrame': 'Change from Baseline to Week 16'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diarrhea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn if using a Entocort (budesonide) to treat diarrhea will be effective and safe for kidney transplant patients, allowing them to continue with MPA medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Kidney transplant recipients \\> 1 months post-transplant,\n* No history of chronic diarrhea pre-transplant,\n* \\>3 watery/soft stools after transplant on at least 4 days in the week without anti-diarrheal for at least 2 weeks or using anti-diarrheals for at least 4 days in the week \\> 2 weeks\n* Subjects on at least 180mg twice a day of mycophenolate-sodium or 250 mg twice a day of cellcept\n\nExclusion Criteria:\n\n* Diagnosis of any known colonic diseases (i.e. Crohn's disease, ulcerative colitis, ischemic colitis, Celiac disease), partial colonic resection, small bowel resection, history of cholecystectomy, Irritable Bowel Syndrome, fecal Incontinence, Bacterial overgrowth, infectious diarrhea (c difficle, cryptospora, giardia, isospora, Human Immunodeficiency Virus), Cytomegalovirus colitis\n* Subjects with recent acute rejection treated with high dose steroids\n* Subjects taking Boswellia serrata extract, over-the-counter herbs, cholestyramine, nonsteroidal salicylates (other than daily ASA)\n* Subjects with active malignancy, liver cirrhosis, active peptic ulcer disease, known intolerance or resistance to budesonide, pregnancy, breast-feeding, mental retardation\n* Unable to provide informed consent"}, 'identificationModule': {'nctId': 'NCT02991768', 'briefTitle': 'Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Budesonide for Mycophenolic Acid (MPA)-Induced Diarrhea in Renal Transplant Recipients', 'orgStudyIdInfo': {'id': 'STUDY00140436'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Entocort EC', 'description': 'Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.', 'interventionNames': ['Drug: Entocort']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will take 6mg matching placebo pill daily for 8 weeks.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Entocort', 'type': 'DRUG', 'otherNames': ['budesonide'], 'description': 'A corticosteroid that decreases levels of inflammatory cytokines.', 'armGroupLabels': ['Entocort EC']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Placebo is matched to the study drug.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Pooja Budhiraja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}