Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

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

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01021943

Enrollment

Registered

2009-12-01

Start date

2009-11-30

Completion date

Unknown

Last updated

2014-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant

Keywords

calcineurin inhibitors, fibrosis, spironolactone, Focus of the study is to assess if aldosterone blockade has an effect on interstitial fibrosis amongst kidney transplant recipients

Brief summary

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

Interventions

DRUGspironolactone

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026