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Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Information source: Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplant

Intervention: spironolactone (Drug); Placebo (Drug)

Phase: Phase 2

Status: Suspended

Sponsored by: Instituto Nacional de Cardiologia Ignacio Chavez

Summary

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

Clinical Details

Official title: The Role of Spironolactone in Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention)

Secondary outcome:

allograft function and proteinuria

Fibrosis markers in kidney biopsies such as TGF-B

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Instituto Nacional Nutricion Salvador Zubiran, Mexico 14080, Mexico
Additional Information

Starting date: November 2009
Last updated: July 23, 2014

Page last updated: August 23, 2015

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