NCT02338635

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Ewha Womans University · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End-Stage Kidney Disease

Interventions

Type	Name	Description
DRUG	Ursodeoxycholic Acid	Inhibition of ER stress (Ursodeoxycholic Acid)

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-01-01
• Completion: 2018-01-01
• First posted: 2015-01-14
• Last updated: 2015-05-15