Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

End Stage Renal Disease Chronic Disease Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritoneal Fibrosis Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, 14080, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age > 18
Hospitalized for peritoneal catheter placement for peritoneal dialysis

Exclusion criteria

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

Treatment and study plan

Spironolactone

Drug

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

Placebo

Drug

Placebo, given daily for 6 months to Peritoneal Dialysis Patients

Primary outcomes

Peritoneal fibrosis

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2012
First posted: Mar 19, 2009
Registry last updated: Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed