Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis

Phase 4

• Conditions: End-Stage Kidney Disease
• Interventions: Drug: Ursodeoxycholic Acid

• Registration Number: NCT02338635
• Lead Sponsor: Ewha Womans University

Brief Summary

Peritoneal fibrosis is one of the major causes of technical failure in patients on peritoneal dialysis (PD) for long period of time. Although the exact mechanisms of peritoneal damage during PD still remain unclear, generation of Endoplasmic reticulum (ER) stress may be responsible for progressive membrane dysfunction. Ursodeoxycholic acid (URSA) is a powerful inhibitor of ER stress to protect peritoneal fibrosis in peritoneal dialysis in the investigators in-vitro study. In this study the researchers investigated the hypothesis that URSA protect peritoneal membrane damage.

Detailed Description

Ursodeoxycholic acid (URSA) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 300 mg per day. Patients will be randomly assigned to URSA and placebo group and prescribed according to the protocol. At 2 and 6 month, Peritoneal equilibrium test (PET) will be performed with blood sampling.

Study Timeline

• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-14
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-05-15
• Study Start: 2015-07
• Primary Completion: 2017-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Maintenance peritoneal dialysis at least 3 months
• Patients who are able and willing to understand, sign and date an informed consent document, and authorize access to protected health information

Exclusion Criteria

• Episode of peritonitis at least 3 months
• Episodes of admission due to other disease at lease 3 months
• Liver disease
• Allergic history with Ursodeoxycholic acid
• Nausea or vomiting after Ursodeoxycholic acid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
URSA group	Ursodeoxycholic Acid	Drug: Ursodeoxycholic acid Other Name: URSAⓇ (Daewoong Pharmaceutical Co., Ltd) Ursodeoxycholic acid (100 mg/tablet) 300 mg/day ( 100mg tid) for 6 months 3 times after meal

Primary Outcome Measures

Name	Time	Method
Peritoneal membrane function	6 months	Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

Secondary Outcome Measures

Name	Time	Method
Oxydative stress	6 months	Measurement of GSH/GSSG, 8-OHdG
Residula renal function	6 months	Changes in estimated GFR
Epithelial to Mesenchymal Transition, EMT	6 months	Phenotypic changes of Mesothelial cells