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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiang Mai University
• Treatments: Losartan; Spironolactone

Criteria

Inclusion Criteria:

• Age ≥ 18 years or older (both male and female patients)

• Incidence or prevalent end-stage kidney disease patients undergoing CAPD

• Had standard dialysis prescription for at least 30 days before screening

• History of hypertension

• Stable clinical condition without any inflammation at least 4 weeks prior to enrolment

• Had an ability to understand and willingness to sign an informed consent statement

Exclusion Criteria:

• Serum potassium concentration of ≥ 5.5 milliequivalent /liter

• History of severe or active cardiovascular and/or cerebrovascular disease

• History of renal artery stenosis

• Uncontrolled hypertension

• Contraindication to angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers or mineralocorticoid receptor antagonists

• Pregnancy

• Recent PD-related peritonitis or exit-site and tunnel infection (within 2 months of screening)

• Had planned to have kidney transplantation or transfer to other PD centers with 6 months

• Prognosis for survival less than 12 months

• Any conditions (both mental or physical) that would interfere with the participant's ability to comply with the study protocol

• Any disease of the abdominal wall, such as injury or surgery, burns, hernia, dermatitis, inflammatory bowel diseases (Crohn's disease, ulcerative colitis or diverticulitis) that in the opinion of the Investigator would preclude the patient from being able to have PD

• Any intra-abdominal tumors or intestinal obstruction

• Current or recent (within 30 days) exposure to others investigational medicinal products