NCT01021943

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

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

First QC Date

November 30, 2009

Last Update Submit

July 23, 2014

Conditions

Kidney Transplant

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention)

    2 years

Secondary Outcomes (2)

  • allograft function and proteinuria

    2 years

  • Fibrosis markers in kidney biopsies such as TGF-B

    2 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

spironolactone

ACTIVE COMPARATOR

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

Drug: spironolactone

Interventions

spironolactoneDRUG

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

spironolactone
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kidney Failure
  • Age \> 18
  • Kidney transplant recipients

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional Nutricion Salvador Zubiran

México, 14080, Mexico

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Nephrology Division

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 1, 2009

Study Start

November 1, 2009

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

ME(1)