Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

July 23, 2014 updated by: Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez

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 Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico, Mexico, 14080
        • Instituto Nacional Nutricion Salvador Zubiran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Half of the subjects will be assigned to receive either spironolactone or placebo for 6 months
Drug: Placebo
Half of the subjects will be assigned to receive placebo for 6 months
ACTIVE_COMPARATOR: spironolactone
Half of the subjects will be randomized to receive spironolactone for 6 months
Drug: spironolactone
Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
allograft function and proteinuria
Time Frame: 2 years
2 years
Fibrosis markers in kidney biopsies such as TGF-B
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (ESTIMATE)

December 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 24, 2014

Last Update Submitted That Met QC Criteria

July 23, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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