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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021943

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

No publications provided

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
Study First Received: November 30, 2009
Last Updated: July 23, 2014
Health Authority: Mexico: Institutional Review Board

Keywords provided by 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
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014