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Effect of Add-on Spironolactone to Losartan Versus Losartan Alone on Peritoneal Membrane Among Peritoneal Dialysis Patients

NCT03953950 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-09-04

No results posted yet for this study

Summary

The ESCAPE-PD (Effects of add-on SpironolaCtone to losartan versus Alone on Peritoneal mEmbrane among continuous ambulatory Peritoneal Dialysis patients) study is a randomized, open-label, single center, active-controlled clinical trial. Adults end-stage kidney disease patients 18 years or older undergoing continuous ambulatory peritoneal dialysis (CAPD) will be enrolled. A total 84 CAPD will be randomly assigned to either the combination of spironolactone and losartan (experimental arm) or losartan alone (control arm). The primary outcomes are the difference in peritoneal dialysate effluent cancer antigen-125 (CA-125) and peritoneal equilibration test (PET) indices (dialysate-to-plasma creatinine ratio, 4-hour ultrafiltration volume, and the concentration of glucose present in the solution at the start of the test). Secondary outcome measures include laboratory and mechanistic outcome measures, nutrition outcomes, health-related quality of life, physical function, clinical events, and safety profiles. Results will be disseminated to suggest a strategy to prevent the peritoneal membrane function among CAPD patients through peer-reviewed publications along with scientific meetings.

Conditions

Interventions

DRUG

Spironolactone

Spironolactone Starting dose: 25 mg/day Target dose: 100 mg/day Titration: every 1-2 weeks, based on BP (keep\< 140/90 mmHg, but avoid hypotension \<90/60 mmHg), and serum potassium level (\<5.5 milliequivalent /liter)

DRUG

Losartan

Losartan Starting dose: 50 mg/day Target dose: 100 mg/day Titration: every 1-2 weeks, based on BP (keep\< 140/90 mmHg, but avoid hypotension \<90/60 mmHg), and serum potassium level (\<5.5 milliequivalent /liter)

Sponsors & Collaborators

  • Chiang Mai University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2020-09-30
Completion
2020-12-31

Countries

  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03953950 on ClinicalTrials.gov