Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

National Institute of Cardiology Ignacio Chavez

Status and phase: Suspended; Phase 2

Conditions: Kidney Transplant

Treatments: Drug: Placebo; Drug: spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT01021943

PT-26

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

spironolactone

Active Comparator group

Description:

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

Treatment:

Drug: spironolactone