Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00865449

Enrollment

Registered

2009-03-19

Start date

2008-07-31

Completion date

2012-03-31

Last updated

2012-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

spironolactone, peritoneal fibrosis, peritoneal dialysis

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.

Interventions

DRUGspironolactone

25 mg daily of spironolactone given for 6 months in the peritoneal dialysis patients

DRUGPlacebo

Placebo, given daily for 6 months to Peritoneal Dialysis Patients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Peritoneal fibrosis	6 months

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026