Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Instituto Nacional de Cardiologia Ignacio Chavez.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:
NCT01021943
First received: November 30, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 30, 2009
November 30, 2009
November 2009
November 2011   (final data collection date for primary outcome measure)
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
No Changes Posted
  • 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.
 
Active, not recruiting
40
November 2011
November 2011   (final data collection date for primary outcome measure)

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
November 2009

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