Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis
Information source: Instituto Nacional de Cardiologia Ignacio Chavez
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease
Intervention: spironolactone (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
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: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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; Recruiting
Magdalena Madero, M.D., Phone: 011 52 1 5555091522, Email: madero.magdalena@gmail.com
Franco Martha, MD, Phone: 01152 5555736902
Magdalena Madero, M.D, Principal Investigator
Additional Information
Starting date: July 2008
Last updated: March 18, 2009
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