The main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin...
Date First Received: November 30, 2009
Last Updated: November 30, 2009
Verified by: Instituto Nacional de Cardiologia Ignacio Chavez, November 2009
Clinical Trial Phase: Phase 2 | Start Date: November 2009
Overall Status: Active, not recruiting
Estimated Enrollment: 40
Brief Summary
Official Title: “The Role of Spironolactone in Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients”
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Intervention(s):
Intervention MeSH Term(s), Assigned with an Experimental Algorithm:
The main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin inhibitors
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Primary Completion Date: November 2011
Intervention(s) in this Clinical Trial
- Drug: spironolactone
- Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months
- Drug: Placebo
- Half of the subjects will be assigned to receive placebo for 6 months
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: Placebo
- Half of the subjects will be assigned to receive either spironolactone or placebo for 6 months
- Active Comparator: spironolactone
- Half of the subjects will be randomized to receive spironolactone for 6 months
Outcome Measures for this Clinical Trial
Primary Measures
- Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention)
- Time Frame: 2 years
Safety Issue?: No
- Time Frame: 2 years
Secondary Measures
- allograft function and proteinuria
- Time Frame: 2 years
Safety Issue?: No
- Time Frame: 2 years
- Fibrosis markers in kidney biopsies such as TGF-B
- Time Frame: 2 years
Safety Issue?: No
- Time Frame: 2 years
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Kidney Failure
- Age > 18
- Kidney transplant recipients
Exclusion Criteria:
- Patients taking angiotensin receptor blockers or inhibitors of the angiotensin reconverting enzyme
- Kidney transplant performed more than one month from enrollment in the study
- Hyperkalemia (K> 5.5 meqL)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Additional Information
Information obtained from ClinicalTrials.gov on September 01, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01021943
Study ID Number: PT-26
ClinicalTrials.gov Identifier: NCT01021943
Health Authority: Mexico: Institutional Review Board
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