Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

NCT ID: NCT01021943

Last Updated: 2014-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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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

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Conditions

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Kidney Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

spironolactone

Half of the subjects will be randomized to receive spironolactone for 6 months

Group Type ACTIVE_COMPARATOR

spironolactone

Intervention Type DRUG

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

Interventions

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spironolactone

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

Sponsor Role lead

Responsible Party

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Magdalena Madero

Chief Nephrology Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto Nacional Nutricion Salvador Zubiran

México, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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PT-26

Identifier Type: -

Identifier Source: org_study_id

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