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

Study Overview
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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.

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.

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

Conditions
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End-Stage Kidney Disease

Intervention / Treatment
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* Drug: Ursodeoxycholic Acid


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: URSA group<br>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 | Drug: Ursodeoxycholic Acid<br>* Inhibition of ER stress (Ursodeoxycholic Acid)<br>* Other names: URSA;|
| Placebo Comparator: Placebo group<br>Placebo drug 1 tablet tid for 6 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peritoneal membrane function | Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ER stress, Peritoneal Dialysis