Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

This study is currently recruiting participants.

Verified by Instituto Nacional de Cardiologia Ignacio Chavez, March 2009

First Received: March 17, 2009 Last Updated: March 18, 2009 History of Changes

Sponsor:	Instituto Nacional de Cardiologia Ignacio Chavez
Information provided by:	Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier:	NCT00865449

Purpose

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.

Condition	Intervention	Phase
End Stage Renal Disease	Drug: spironolactone Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Spironolactone

U.S. FDA Resources

Further study details as provided by Instituto Nacional de Cardiologia Ignacio Chavez:

Primary Outcome Measures:

Peritoneal fibrosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Peritoneal Dialysis patients on aldactone for 6 months	Drug: spironolactone 25 mg daily of spironolactone given for 6 months in the peritoneal dialysis patients
2: Placebo Comparator Peritoneal dialysis Patients on the placebo arm for 6 months	Drug: Placebo Placebo, given daily for 6 months to Peritoneal Dialysis Patients

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18
Hospitalized for peritoneal catheter placement for peritoneal dialysis

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865449

Locations

Mexico, DF
Instituto Nacional de Cardiologia Ignacio Chavez	Recruiting
Mexico, DF, Mexico, 14080
Contact: Magdalena Madero, M.D. 011 52 1 5555091522 madero.magdalena@gmail.com
Contact: Franco Martha, MD 01152 5555736902
Principal Investigator: Magdalena Madero, M.D

Sponsors and Collaborators

Instituto Nacional de Cardiologia Ignacio Chavez

Investigators

Principal Investigator:

Magdalena Madero, M.D

Instituto Nacional de Cardiologia Ignacio Chavez

More Information

No publications provided

Responsible Party:	Instituto Nacional de Cardiologia Ignacio Chavez ( Magdalena Madero )
Study ID Numbers:	08-590
Study First Received:	March 17, 2009
Last Updated:	March 18, 2009
ClinicalTrials.gov Identifier:	NCT00865449 History of Changes
Health Authority:	Mexico: Ethics Committee

Keywords provided by Instituto Nacional de Cardiologia Ignacio Chavez:

spironolactone
peritoneal fibrosis
peritoneal dialysis

Additional relevant MeSH terms:

Renal Insufficiency
Fibrosis
Hormone Antagonists
Diuretics
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Kidney Failure, Chronic
Cardiovascular Agents
Pharmacologic Actions

Spironolactone
Pathologic Processes
Aldosterone Antagonists
Urologic Diseases
Renal Insufficiency, Chronic
Natriuretic Agents
Therapeutic Uses
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010