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

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ClinicalTrials.gov Identifier: NCT02338635
Recruitment Status : Unknown
Verified May 2015 by Duk-Hee Kang, Ewha Womans University.
Recruitment status was:  Not yet recruiting
First Posted : January 14, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Duk-Hee Kang, Ewha Womans University

Brief 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.

Condition or disease Intervention/treatment Phase
End-Stage Kidney Disease Drug: Ursodeoxycholic Acid Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis
Study Start Date : July 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ursodiol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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
Drug: Ursodeoxycholic Acid
Inhibition of ER stress (Ursodeoxycholic Acid)
Other Name: URSA
Placebo Comparator: Placebo group
Placebo drug 1 tablet tid for 6 months



Primary Outcome Measures :
  1. Peritoneal membrane function [ Time Frame: 6 months ]
    Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test


Secondary Outcome Measures :
  1. Residula renal function [ Time Frame: 6 months ]
    Changes in estimated GFR

  2. Epithelial to Mesenchymal Transition, EMT [ Time Frame: 6 months ]
    Phenotypic changes of Mesothelial cells

  3. Oxydative stress [ Time Frame: 6 months ]
    Measurement of GSH/GSSG, 8-OHdG



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338635


Contacts
Contact: Mina Yu, MD +82-10-5096-7285 yuelizabeth@hanmail.net
Contact: Hyun-Jung Kim, NR 40739@eumc.co.kr

Sponsors and Collaborators
Ewha Womans University
Investigators
Principal Investigator: Duk-Hee Kang, MD. PhD. Ewha Womans University Mokdong Hospital

Responsible Party: Duk-Hee Kang, Professor, Ewha Womans University
ClinicalTrials.gov Identifier: NCT02338635     History of Changes
Other Study ID Numbers: URSA-1
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: May 2015

Keywords provided by Duk-Hee Kang, Ewha Womans University:
ER stress
Peritoneal Dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents