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

Condition Intervention Phase
Kidney Transplant Drug: spironolactone Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Spironolactone in Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez:

Primary Outcome Measures:
  • Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention) [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • allograft function and proteinuria [ Time Frame: 2 years ]
  • Fibrosis markers in kidney biopsies such as TGF-B [ Time Frame: 2 years ]

Estimated Enrollment: 40
Study Start Date: November 2009
Arms Assigned Interventions
Placebo Comparator: Placebo
Half of the subjects will be assigned to receive either spironolactone or placebo for 6 months
Drug: Placebo
Half of the subjects will be assigned to receive placebo for 6 months
Active Comparator: spironolactone
Half of the subjects will be randomized to receive spironolactone for 6 months
Drug: spironolactone
Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021943


Locations
Mexico
Instituto Nacional Nutricion Salvador Zubiran
Mexico, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
  More Information

Responsible Party: Magdalena Madero, Chief Nephrology Division, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT01021943     History of Changes
Other Study ID Numbers: PT-26
First Submitted: November 30, 2009
First Posted: December 1, 2009
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez:
calcineurin inhibitors
fibrosis
spironolactone
Focus of the study is to assess if aldosterone blockade has an effect on interstitial fibrosis amongst kidney transplant recipients

Additional relevant MeSH terms:
Spironolactone
Calcineurin Inhibitors
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action