Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients
NCT ID: NCT01021943
Last Updated: 2014-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
40 participants
INTERVENTIONAL
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Half of the subjects will be assigned to receive either spironolactone or placebo for 6 months
Placebo
Half of the subjects will be assigned to receive placebo for 6 months
spironolactone
Half of the subjects will be randomized to receive spironolactone for 6 months
spironolactone
Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months
Interventions
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spironolactone
Half of the subjects will be assigned to receive 25 mg of spironolactone for 6 months
Placebo
Half of the subjects will be assigned to receive placebo for 6 months
Eligibility Criteria
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Inclusion Criteria
* Age \> 18
* Kidney transplant recipients
Exclusion Criteria
* Kidney transplant performed more than one month from enrollment in the study
* Hyperkalemia (K\> 5.5 meqL)
18 Years
ALL
No
Sponsors
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Instituto Nacional de Cardiologia Ignacio Chavez
OTHER
Responsible Party
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Magdalena Madero
Chief Nephrology Division
Locations
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Instituto Nacional Nutricion Salvador Zubiran
México, , Mexico
Countries
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Other Identifiers
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PT-26
Identifier Type: -
Identifier Source: org_study_id
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