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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
History of Changes
  Purpose

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 Intervention Phase
End Stage Renal Disease
 Drug: spironolactone
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Peritoneal fibrosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2008
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Magdalena Madero, MD, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT00865449     History of Changes
Other Study ID Numbers: 08-590
Study First Received: March 17, 2009
Last Updated: October 23, 2012
Health Authority: Mexico: Ethics Committee

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

Additional relevant MeSH terms:
Fibrosis
Kidney Diseases
Kidney Failure, Chronic
Peritoneal Fibrosis
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Peritoneal Diseases
Digestive System Diseases
 Spironolactone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013