Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-01 @ 9:46 AM
Study NCT ID:
NCT02738905
Status:
WITHDRAWN
Last Update Posted:
2019-02-28
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078262', 'term': 'Rifaximin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'insufficient support', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum TMAO levels', 'timeFrame': 'Change from Baseline to Day 7'}], 'secondaryOutcomes': [{'measure': 'Change in serum TMAO levels', 'timeFrame': 'Change from Baseline to Day 21'}, {'measure': 'Change in fecal bacterial species', 'timeFrame': 'Change from Baseline to Day 7'}, {'measure': 'Change in fecal bacterial colony numbers', 'timeFrame': 'Change from Baseline to Day 7'}, {'measure': 'Change in fecal bacterial species', 'timeFrame': 'Change from Baseline to Day 21'}, {'measure': 'Change in fecal bacterial colony numbers', 'timeFrame': 'Change from Baseline to Day 21'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if rifaximin reduces serum trimethylamine-N-oxide (TMAO) levels in patients with end-stage renal disease.', 'detailedDescription': 'Study participants will undergo 3 study visits: baseline, day 7 (immediately post-therapy), day 21 (2 weeks post-therapy). All participants will provide blood and stool samples at each visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of end-stage renal disease\n* Receiving chronic intermittent hemodialysis\n\nExclusion Criteria:\n\n* Patients with less advanced kidney disease\n* Inability or unwillingness to provide informed consent\n* Patients who may be pregnant\n* Hemodynamically unstable patients\n* Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease\n* Patients with ongoing or recent infection and those with history of C-diff infection\n* Patients with abnormal bowel structure secondary to surgical or anatomic variations\n* Patients on certain medications, including immunosuppressants, antidiarrheal agents, or recent (within the last 2 months) use of antibiotics'}, 'identificationModule': {'nctId': 'NCT02738905', 'briefTitle': 'Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Impact of Rifaximin Therapy on Intestinal Byproducts in End-Stage Renal Disease', 'orgStudyIdInfo': {'id': 'STUDY00004204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rifaximin', 'description': 'Participants will receive study drug for a period of 7 days.', 'interventionNames': ['Drug: Rifaximin']}], 'interventions': [{'name': 'Rifaximin', 'type': 'DRUG', 'otherNames': ['XIFAXAN'], 'description': 'One 550 mg tablet taken orally two times a day.', 'armGroupLabels': ['Rifaximin']}]}, '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}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'Westwood Dialysis Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}], 'overallOfficials': [{'name': 'Jason Stubbs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jason Stubbs, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jason Stubbs, MD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}