Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:
NCT01021943
First received: November 30, 2009
Last updated: July 23, 2014
Last verified: July 2014

November 30, 2009
July 23, 2014
November 2009
Not Provided
Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01021943 on ClinicalTrials.gov Archive Site
  • allograft function and proteinuria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Fibrosis markers in kidney biopsies such as TGF-B [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Kidney Transplant
  • Drug: spironolactone
    Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months
  • Drug: Placebo
    Half of the subjects will be assigned to receive placebo for 6 months
  • Placebo Comparator: Placebo
    Half of the subjects will be assigned to receive either spironolactone or placebo for 6 months
    Intervention: Drug: Placebo
  • Active Comparator: spironolactone
    Half of the subjects will be randomized to receive spironolactone for 6 months
    Intervention: Drug: spironolactone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
40
Not Provided
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01021943
PT-26
Yes
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
Instituto Nacional de Cardiologia Ignacio Chavez
Not Provided
Not Provided
Instituto Nacional de Cardiologia Ignacio Chavez
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP