Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

Phase 3

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: spironolactone; Drug: Placebo

• Registration Number: NCT00865449
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Status Verified: 2009-03
• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Primary Completion: 2011-12
• Study Completion: 2012-03
• Last Update Submitted: 2012-10-23
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	spironolactone	Peritoneal Dialysis patients on aldactone for 6 months
2	Placebo	Peritoneal dialysis Patients on the placebo arm for 6 months

Primary Outcome Measures

Name	Time	Method
Peritoneal fibrosis	6 months

Trial Locations

Locations (1)

Instituto Nacional de Cardiologia Ignacio Chavez; 🇲🇽 Mexico, DF, Mexico