Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT00507494
Status:
COMPLETED
Last Update Posted:
2011-10-28
First Post:
2007-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Pioglitazone for Renal Transplant Function in Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-27', 'studyFirstSubmitDate': '2007-07-25', 'studyFirstSubmitQcDate': '2007-07-25', 'lastUpdatePostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proteinuria', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['posttransplant diabetes mellitus', 'kidney transplantation', 'filtration fraction', 'proteinuria'], 'conditions': ['Diabetes Mellitus', 'Kidney Transplantation', 'Proteinuria']}, 'referencesModule': {'references': [{'pmid': '32803882', 'type': 'DERIVED', 'citation': 'Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether pioglitazone is able to prevent the progression of diabetic nephropathy in kidney transplant recipients with diabetes mellitus.', 'detailedDescription': 'About 30 % of kidney transplant recipients will develop diabetes mellitus. This condition is a risk factor for graft dysfunction, graft loss and increased mortality of patients. Inflammatory reactions within the graft and proteinuria are considered as pathogenetic mechanisms.\n\nRecent studies indicated that pioglitazone might have beneficial effects on the urinary protein excretion of type 2 diabetic patients with diabetic nephropathy and was able to reduce systemic inflammation.\n\nThis lead to the hypothesis that pioglitazone could improve proteinuria of kidney transplant patients with diabetes.\n\nComparison: Effects of pioglitazone vs. placebo on proteinuria and renal function of kidney transplant recipients in a cross over study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* kidney transplantation(\\> 6 months ago) ; stable graft function\n* diabetes mellitus type 2\n* acceptable glycemia (HbA1c \\< 8%)\n* creatinin clearance (MDRD)\\>30 ml/min 1,73m²)\n* proteinuria \\> 30 mg/24 hr\n\nExclusion Criteria:\n\n* type 1 diabetes\n* pregnant or breast feeding women\n* congestive heart failure (\\>stage 1 NYHA)\n* creeping creatinin\n* treatment for rejection within 3 months prior to inclusion\n* ALT, AST \\> 2.5 fold the upper limit of normal\n* uncontrolled hypertension\n* hypo- or hyperthyroidism'}, 'identificationModule': {'nctId': 'NCT00507494', 'briefTitle': 'Influence of Pioglitazone for Renal Transplant Function in Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Influence of Pioglitazone for Renal Transplant Function in Diabetics - a Double Blind Randomised Placebo Controlled Cross Over Study', 'orgStudyIdInfo': {'id': 'DNTx'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pioglitazone', 'type': 'DRUG', 'description': 'Pioglitazone 30 mg o.d. tablet for 12 weeks or placebo o.d. tablet for 12 weeks in random order. After 12 wk treatment there is a 4 wk washout out which is followed by switch of study medication in a cross over fashion and a further 12 wk treatment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Nephrology, Department of Medicine, university hospital Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Peter Gross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nephrology, Department of Medicine, University hospital Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}