Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-02-24 @ 6:13 AM
Study NCT ID:
NCT02338635
Status:
UNKNOWN
Last Update Posted:
2015-05-15
First Post:
2015-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis
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': 'D014580', 'term': 'Ursodeoxycholic Acid'}], 'ancestors': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-13', 'studyFirstSubmitDate': '2015-01-12', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peritoneal membrane function', 'timeFrame': '6 months', 'description': 'Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test'}], 'secondaryOutcomes': [{'measure': 'Residula renal function', 'timeFrame': '6 months', 'description': 'Changes in estimated GFR'}, {'measure': 'Epithelial to Mesenchymal Transition, EMT', 'timeFrame': '6 months', 'description': 'Phenotypic changes of Mesothelial cells'}, {'measure': 'Oxydative stress', 'timeFrame': '6 months', 'description': 'Measurement of GSH/GSSG, 8-OHdG'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ER stress', 'Peritoneal Dialysis'], 'conditions': ['End-Stage Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage during PD still remain unclear, generation of Endoplasmic reticulum (ER) stress may be responsible for progressive membrane dysfunction. Ursodeoxycholic acid (URSA) is a powerful inhibitor of ER stress to protect peritoneal fibrosis in peritoneal dialysis in the investigators in-vitro study. In this study the researchers investigated the hypothesis that URSA protect peritoneal membrane damage.', 'detailedDescription': 'Ursodeoxycholic acid (URSA) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 300 mg per day. Patients will be randomly assigned to URSA and placebo group and prescribed according to the protocol. At 2 and 6 month, Peritoneal equilibrium test (PET) will be performed with blood sampling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maintenance peritoneal dialysis at least 3 months\n* Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information\n\nExclusion Criteria:\n\n* Episode of peritonitis at least 3 months\n* Episodes of admission due to other disease at lease 3 months\n* Liver disease\n* Allergic history with Ursodeoxycholic acid\n* Nausea or vomiting after Ursodeoxycholic acid'}, 'identificationModule': {'nctId': 'NCT02338635', 'briefTitle': 'Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis', 'orgStudyIdInfo': {'id': 'URSA-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'URSA group', 'description': 'Drug: Ursodeoxycholic acid Other Name: URSAⓇ (Daewoong Pharmaceutical Co., Ltd) Ursodeoxycholic acid (100 mg/tablet) 300 mg/day ( 100mg tid) for 6 months 3 times after meal', 'interventionNames': ['Drug: Ursodeoxycholic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo drug 1 tablet tid for 6 months'}], 'interventions': [{'name': 'Ursodeoxycholic Acid', 'type': 'DRUG', 'otherNames': ['URSA'], 'description': 'Inhibition of ER stress (Ursodeoxycholic Acid)', 'armGroupLabels': ['URSA group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mina Yu, MD', 'role': 'CONTACT', 'email': 'yuelizabeth@hanmail.net', 'phone': '+82-10-5096-7285'}, {'name': 'Hyun-Jung Kim, NR', 'role': 'CONTACT', 'email': '40739@eumc.co.kr'}], 'overallOfficials': [{'name': 'Duk-Hee Kang, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ewha Womans University Mokdong Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Duk-Hee Kang', 'investigatorAffiliation': 'Ewha Womans University'}}}}