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Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:
NCT00865449
First received: March 17, 2009
Last updated: October 23, 2012
Last verified: March 2009

March 17, 2009
October 23, 2012
July 2008
December 2011   (final data collection date for primary outcome measure)
Peritoneal fibrosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865449 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis
Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients

This is a double blind randomized controlled study to evaluate the effect of aldactone on peritoneal fibrosis on incident peritoneal dialysis patients. The study would include a total of 40 incident peritoneal dialysis patients. Peritoneal biopsy would be made at randomization and 6 months after the intervention to evaluate the effect of renin angiotensin blockade on peritoneal fibrosis.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
End Stage Renal Disease
  • Drug: spironolactone
    25 mg daily of spironolactone given for 6 months in the peritoneal dialysis patients
  • Drug: Placebo
    Placebo, given daily for 6 months to Peritoneal Dialysis Patients
  • Active Comparator: 1
    Peritoneal Dialysis patients on aldactone for 6 months
    Intervention: Drug: spironolactone
  • Placebo Comparator: 2
    Peritoneal dialysis Patients on the placebo arm for 6 months
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18
  • Hospitalized for peritoneal catheter placement for peritoneal dialysis

Exclusion Criteria:

  • Pregnancy
  • Hiperkalemia (K> 5.5meq/l)
  • Intolerance to spironolactone
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00865449
08-590
No
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
Instituto Nacional de Cardiologia Ignacio Chavez
Not Provided
Principal Investigator: Magdalena Madero, M.D Instituto Nacional de Cardiologia Ignacio Chavez
Instituto Nacional de Cardiologia Ignacio Chavez
March 2009

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