Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

October 23, 2012 updated by: Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • DF
      • Mexico, DF, Mexico, 14080
        • Instituto Nacional de Cardiologia Ignacio Chavez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18
  • Hospitalized for peritoneal catheter placement for peritoneal dialysis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peritoneal fibrosis
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Investigators

  • Principal Investigator: Magdalena Madero, M.D, Instituto Nacional de Cardiologia Ignacio Chavez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Estimate)

October 25, 2012

Last Update Submitted That Met QC Criteria

October 23, 2012

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-590

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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