Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

National Institute of Cardiology Ignacio Chavez

Status and phase: Completed; Phase 3

Conditions: End Stage Renal Disease

Treatments: Drug: spironolactone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00865449

08-590

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Peritoneal Dialysis patients on aldactone for 6 months

Treatment:

Drug: spironolactone

2

Placebo Comparator group

Description:

Peritoneal dialysis Patients on the placebo arm for 6 months

Treatment:

Drug: Placebo