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| 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients |
| 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 |
|---|---|
|
Active Comparator: 1
Peritoneal Dialysis patients on aldactone for 6 months
|
Drug: spironolactone
25 mg daily of spironolactone given for 6 months in the peritoneal dialysis patients
|
|
Placebo Comparator: 2
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Mexico | |
| 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 | |
| Principal Investigator: | Magdalena Madero, M.D | Instituto Nacional de Cardiologia Ignacio Chavez |
More Information
| Responsible Party: | Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez |
| ClinicalTrials.gov Identifier: | NCT00865449 History of Changes |
| Other Study ID Numbers: | 08-590 |
| Study First Received: | March 17, 2009 |
| Last Updated: | March 18, 2009 |
| Health Authority: | Mexico: Ethics Committee |
|
spironolactone peritoneal fibrosis peritoneal dialysis |
|
Fibrosis Kidney Diseases Kidney Failure, Chronic Peritoneal Fibrosis Pathologic Processes Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Peritoneal Diseases Digestive System Diseases |
Spironolactone Aldosterone Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Diuretics Natriuretic Agents Cardiovascular Agents Therapeutic Uses |
