Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Verified by: Instituto Nacional de Cardiologia Ignacio Chavez, November 2009
First Received: November 30, 2009 | Last Updated: November 30, 2009 | Phase: Phase 2 | Start Date: November 2009
Overall Status: Active, not recruiting | Estimated Enrollment: 40
  • …
  • Tell a FriendPrint

The main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin...

Brief Summary

Official Title: “The Role of Spironolactone in Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients”

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, 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

Secondary Measures

  • allograft function and proteinuria
    • Time Frame: 2 years
      Safety Issue?: No
  • Fibrosis markers in kidney biopsies such as TGF-B
    • Time Frame: 2 years
      Safety Issue?: No

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 Investigator Information

Lead Investigator: Instituto Nacional de Cardiologia Ignacio Chavez Other

Additional Information

Information obtained from ClinicalTrials.gov on February 02, 2012

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

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01021943