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Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

NCT ID: NCT00865449

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Renal Disease

Keywords

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spironolactone peritoneal fibrosis peritoneal dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Peritoneal Dialysis patients on aldactone for 6 months

Group Type ACTIVE_COMPARATOR

spironolactone

Intervention Type DRUG

25 mg daily of spironolactone given for 6 months in the peritoneal dialysis patients

2

Peritoneal dialysis Patients on the placebo arm for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, given daily for 6 months to Peritoneal Dialysis Patients

Interventions

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spironolactone

25 mg daily of spironolactone given for 6 months in the peritoneal dialysis patients

Intervention Type DRUG

Placebo

Placebo, given daily for 6 months to Peritoneal Dialysis Patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Hospitalized for peritoneal catheter placement for peritoneal dialysis

Exclusion Criteria

* Pregnancy
* Hiperkalemia (K\> 5.5meq/l)
* Intolerance to spironolactone
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

Sponsor Role lead

Responsible Party

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Magdalena Madero

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magdalena Madero, M.D

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cardiologia Ignacio Chavez

Locations

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Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

References

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Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.

Reference Type DERIVED
PMID: 33586138 (View on PubMed)

Other Identifiers

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08-590

Identifier Type: -

Identifier Source: org_study_id