Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Phase 2SuspendedNCT01021943

Instituto Nacional de Cardiologia Ignacio Chavez40 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Kidney Transplant

Interventions

spironolactoneDRUG

Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months

PlaceboDRUG

Half of the subjects will be assigned to receive placebo for 6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Instituto Nacional Nutricion Salvador Zubiran

México, Mexico

Outcomes

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

allograft function and proteinuria

Time frame: 2 years

Fibrosis markers in kidney biopsies such as TGF-B

Time frame: 2 years

Data from ClinicalTrials.gov

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