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Clinical Trial Details

Trial ID: L1219
Source ID: NCT03953950
Associated Drug: Spironolactone
Title: Effect of Add-on Spironolactone to Losartan Versus Losartan Alone on Peritoneal Membrane Among Peritoneal Dialysis Patients
Acronym: ESCAPE-PD
Status: UNKNOWN
Study Results: NO
Results:
Conditions: End Stage Renal Disease|Peritoneal Dialysis
Interventions: DRUG: Spironolactone|DRUG: Losartan
Outcome Measures: Primary: Peritoneal dialysate effluent CA-125, Using a commercial microparticle enzyme-linked immunosorbent assay, 6 months|PET indices, PET indices including dialysate-to-plasma creatinine ratio \[D/P Cr\], 4-hour ultrafiltration (UF) volume, and the concentration of glucose present in the solution at the start of the test \[D/D0\]) measured using a modified PET method (performed using 2,000 mL of 2.5% glucose solution)., 6 months | Secondary: Changes in dialysate adequacy by Weekly kt/V, 6 months|Changes in dialysate adequacy by weekly creatinine clearance, 6 months|Changes in serum albumin concentration, 6 months|Changes in serum potassium concentration, 6 months|Changes in waist circumference, 6 months|Changes in body mass index (BMI), Weight and height will be combined to report BMI in kg/m\^2, 6 months|Changes in Nutritional status, Using Subjective Global Assessment (SGA), 6 months|Changes in Malnutrition-Inflammation Score (MIS), 6 months|Changes in participant quality of life score, Using Kidney Disease Quality of Life-36 (KDQOL-36 Version 1.3), 6 months|Changes in health utility, Using EuroQOL-5 dimension 5-level (EQ-5D-5L), 6 months|Changes in disease-specific Thai quality of life score, Using the 9-Thai Health status AssessmentInstrument (9-THAI) questionnaire, 6 months|Changes in participant well-being score, Using the World Health Organization-Five (WHO-5) well-being index, 6 months|Number of participants with disability, Using the Barthel activities daily life index, 6 months | Other: Changes in blood pressure, 6 months|Incidence of PD technique failure, 6 months|Incidence of PD-related infections, Peritonitis or exit-site and tunnel infection, 6 months|Number of participants with investigational medicinal products-related adverse events as assessed by CTCAE v4.0, Safety of investigational medicinal products related to potential harm (e.g. death, hospitalization, and emergency visit), 6 months
Sponsor/Collaborators: Sponsor: Chiang Mai University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 84
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2019-10
Completion Date: 2020-12
Results First Posted:
Last Update Posted: 2019-09-04
Locations: Pharmacoepidemiology and Statistics Research Center, Faculty of Pharmacy, Chiang Mai University, Chiang Mai, 50200, Thailand
URL: https://clinicaltrials.gov/show/NCT03953950