Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez (Other)
• Overall Status: Completed
• CT.gov ID: NCT00865449
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 44
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Jul 1, 2008
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Peritoneal fibrosis [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Magdalena Madero, MD, Instituto Nacional de Cardiologia Ignacio Chavez
• ClinicalTrials.gov Identifier: NCT00865449
• Other Study ID Numbers: 08-590
• First Posted: Mar 19, 2009
• Last Update Posted: Oct 25, 2012
• Last Verified: Mar 1, 2009

• Keywords provided by Magdalena Madero, MD, Instituto Nacional de Cardiologia Ignacio Chavez: spironolactone; peritoneal fibrosis; peritoneal dialysis
• Additional relevant MeSH terms: Peritoneal Fibrosis; Kidney Failure, Chronic; Fibrosis; Spironolactone

Study Results

No Results Posted as of Oct 25, 2012