Spironolactone and Prevention of Peritoneal Fibrosis in P... | NCT00865449

Studies
Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

NCT00865449

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Status

Completed

Last Update Posted

Oct 25, 2012Estimated

Enrollment

20Actual

Phase

Phase 3

Conditions

End Stage Renal Disease

Interventions

spironolactone
Placebo

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Mar 2012Actual

First Submitted Date

Mar 17, 2009

First Submission Date that Met QC Criteria

Mar 18, 2009

First Posted Date

Mar 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2012

Last Update Posted Date

Oct 25, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Magdalena Madero, MD, Instituto Nacional de Cardiologia Ignacio ChavezPrincipal Investigator

Lead Sponsor

Instituto Nacional de Cardiologia Ignacio ChavezOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Peritoneal Dialysis patients on aldactone for 6 months	Drug: spironolactone
2	Placebo Comparator	Peritoneal dialysis Patients on the placebo arm for 6 months	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spironolactone	Drug	25 mg daily of spironolactone given for 6 months in the peritoneal dialysis patients	1

Measure	Description	Time Frame
Peritoneal fibrosis		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Magdalena Madero, M.D	Instituto Nacional de Cardiologia Ignacio Chavez	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Cardiologia Ignacio Chavez		Mexico City	Mexico City	14080	Mexico

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33586138	Derived	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.

ID	Term
D007676	Kidney Failure, Chronic
D056627	Peritoneal Fibrosis

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256