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

Ewha Womans University

Status and phase: Unknown; Phase 4

Conditions: End-Stage Kidney Disease

Treatments: Drug: Ursodeoxycholic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02338635

URSA-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 2 patient groups, including a placebo group

URSA group

Experimental group

Description:

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

Treatment:

Drug: Ursodeoxycholic Acid

Placebo group

Placebo Comparator group

Description:

Placebo drug 1 tablet tid for 6 months