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Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021943
First Posted: December 1, 2009
Last Update Posted: July 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
November 30, 2009
December 1, 2009
July 24, 2014
November 2009
Not Provided
Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention) [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01021943 on ClinicalTrials.gov Archive Site
  • allograft function and proteinuria [ Time Frame: 2 years ]
  • Fibrosis markers in kidney biopsies such as TGF-B [ Time Frame: 2 years ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT01021943
PT-26
Yes
Not Provided
Not Provided
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