Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Phase 2

Suspended

• Conditions: Kidney Transplant
• Interventions: Drug: Placebo; Drug: spironolactone

• Registration Number: NCT01021943
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-01
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-23
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Half of the subjects will be assigned to receive either spironolactone or placebo for 6 months
spironolactone	spironolactone	Half of the subjects will be randomized to receive spironolactone for 6 months

Primary Outcome Measures

Name	Time	Method
Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention)	2 years

Secondary Outcome Measures

Name	Time	Method
allograft function and proteinuria	2 years
Fibrosis markers in kidney biopsies such as TGF-B	2 years

Trial Locations

Locations (1)

Instituto Nacional Nutricion Salvador Zubiran; 🇲🇽 Mexico, Mexico