NCT00865449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

October 25, 2012

Status Verified

March 1, 2009

Enrollment Period

3.4 years

First QC Date

March 17, 2009

Last Update Submit

October 23, 2012

Conditions

End Stage Renal Disease

Keywords

spironolactoneperitoneal fibrosisperitoneal dialysis

Outcome Measures

Primary Outcomes (1)

  • Peritoneal fibrosis

    6 months

Study Arms (2)

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

spironolactoneDRUG

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

1
PlaceboDRUG

Placebo, given daily for 6 months to Peritoneal Dialysis Patients

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 33586138DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicPeritoneal Fibrosis

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPeritoneal DiseasesDigestive System DiseasesFibrosis

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Magdalena Madero, M.D

    Instituto Nacional de Cardiologia Ignacio Chavez

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 19, 2009

Study Start

July 1, 2008

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

October 25, 2012

Record last verified: 2009-03

Locations

ME(1)