Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
spironolactone
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring spironolactone, peritoneal fibrosis, peritoneal dialysis
Eligibility Criteria
Inclusion Criteria:
- Age > 18
- Hospitalized for peritoneal catheter placement for peritoneal dialysis
Exclusion Criteria:
- Pregnancy
- Hiperkalemia (K> 5.5meq/l)
- Intolerance to spironolactone
Sites / Locations
- Instituto Nacional de Cardiologia Ignacio Chavez
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Peritoneal Dialysis patients on aldactone for 6 months
Peritoneal dialysis Patients on the placebo arm for 6 months
Outcomes
Primary Outcome Measures
Peritoneal fibrosis
Secondary Outcome Measures
Full Information
NCT ID
NCT00865449
First Posted
March 17, 2009
Last Updated
October 23, 2012
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
1. Study Identification
Unique Protocol Identification Number
NCT00865449
Brief Title
Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis
Official Title
Role of Renin Angiotensin Blockade in Peritoneal Fibrosis in Peritoneal Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
spironolactone, peritoneal fibrosis, peritoneal dialysis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Peritoneal Dialysis patients on aldactone for 6 months
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Peritoneal dialysis Patients on the placebo arm for 6 months
Intervention Type
Drug
Intervention Name(s)
spironolactone
Intervention Description
25 mg daily of spironolactone given for 6 months in the peritoneal dialysis patients
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, given daily for 6 months to Peritoneal Dialysis Patients
Primary Outcome Measure Information:
Title
Peritoneal fibrosis
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18
Hospitalized for peritoneal catheter placement for peritoneal dialysis
Exclusion Criteria:
Pregnancy
Hiperkalemia (K> 5.5meq/l)
Intolerance to spironolactone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Madero, M.D
Organizational Affiliation
Instituto Nacional de Cardiologia Ignacio Chavez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Cardiologia Ignacio Chavez
City
Mexico
State/Province
DF
ZIP/Postal Code
14080
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
33586138
Citation
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.
Results Reference
derived
Learn more about this trial
Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis
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