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Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

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ClinicalTrials.gov Identifier: NCT00865449
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: spironolactone Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients
Study Start Date : July 2008
Primary Completion Date : December 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Peritoneal Dialysis patients on aldactone for 6 months
Drug: spironolactone
25 mg daily of spironolactone given for 6 months in the peritoneal dialysis patients
Placebo Comparator: 2
Peritoneal dialysis Patients on the placebo arm for 6 months
Drug: Placebo
Placebo, given daily for 6 months to Peritoneal Dialysis Patients



Primary Outcome Measures :
  1. Peritoneal fibrosis [ Time Frame: 6 months ]


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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:

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

Exclusion Criteria:

  • Pregnancy
  • Hiperkalemia (K> 5.5meq/l)
  • Intolerance to spironolactone

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): NCT00865449


Locations
Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico, DF, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Investigators
Principal Investigator: Magdalena Madero, M.D Instituto Nacional de Cardiologia Ignacio Chavez

Responsible Party: Magdalena Madero, MD, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT00865449     History of Changes
Other Study ID Numbers: 08-590
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: October 25, 2012
Last Verified: March 2009

Keywords provided by Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez:
spironolactone
peritoneal fibrosis
peritoneal dialysis

Additional relevant MeSH terms:
Fibrosis
Kidney Failure, Chronic
Peritoneal Fibrosis
Pathologic Processes
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Peritoneal Diseases
Digestive System Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents