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

End-Stage Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02338635
• Other study ID #: URSA-1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 12, 2015
• Last updated: May 13, 2015
• Start date: July 2015
• Est. completion date: January 2018

Study information

• Verified date: May 2015
• Source: Ewha Womans University
• Contact: Mina Yu, MD
• Phone: +82-10-5096-7285
• Email: yuelizabeth[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Ursodeoxycholic Acid
Inhibition of ER stress (Ursodeoxycholic Acid)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peritoneal membrane function	Changes in peritoneal membrane function (? D/Pcreatinine, ?D/Purea) with peritoneal equilibrium test	6 months	No
Secondary	Residula renal function	Changes in estimated GFR	6 months	No
Secondary	Epithelial to Mesenchymal Transition, EMT	Phenotypic changes of Mesothelial cells	6 months	No
Secondary	Oxydative stress	Measurement of GSH/GSSG, 8-OHdG	6 months	No