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NCT01021943 Clinical Trial

Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Kidney Transplant Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT01021943
Other study ID # PT-26
Secondary ID
Status Suspended
Phase Phase 2
First received November 30, 2009
Last updated July 23, 2014
Start date November 2009

Study information
Verified date July 2014
Source Instituto Nacional de Cardiologia Ignacio Chavez
Contact n/a
Is FDA regulated No
Health authority Mexico: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Suspended
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• spironolactone
Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months
• Placebo
Half of the subjects will be assigned to receive placebo for 6 months

Locations
Country Name City State
Mexico Instituto Nacional Nutricion Salvador Zubiran Mexico

Sponsors (1)
Lead Sponsor Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention) 2 years No
Secondary allograft function and proteinuria 2 years No
Secondary Fibrosis markers in kidney biopsies such as TGF-B 2 years No
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