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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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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

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End-Stage Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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URSA group

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

Group Type EXPERIMENTAL

Ursodeoxycholic Acid

Intervention Type DRUG

Inhibition of ER stress (Ursodeoxycholic Acid)

Placebo group

Placebo drug 1 tablet tid for 6 months

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Ursodeoxycholic Acid

Inhibition of ER stress (Ursodeoxycholic Acid)

Intervention Type DRUG

Other Intervention Names

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URSA

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No