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Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

Information source: Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End Stage Renal Disease

Intervention: spironolactone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Instituto Nacional de Cardiologia Ignacio Chavez

Official(s) and/or principal investigator(s):
Magdalena Madero, M.D, Principal Investigator, Affiliation: Instituto Nacional de Cardiologia Ignacio Chavez

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.

Clinical Details

Official title: Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Peritoneal fibrosis

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age > 18

- Hospitalized for peritoneal catheter placement for peritoneal dialysis

Exclusion Criteria:

- Pregnancy

- Hiperkalemia (K> 5. 5meq/l)

- Intolerance to spironolactone

Locations and Contacts

Instituto Nacional de Cardiologia Ignacio Chavez, Mexico, DF 14080, Mexico
Additional Information

Starting date: July 2008
Last updated: October 23, 2012

Page last updated: August 23, 2015

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