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

Primary Purpose

End-Stage Kidney Disease

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ursodeoxycholic Acid
Sponsored by
Ewha Womans University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Kidney Disease focused on measuring ER stress, Peritoneal Dialysis

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    URSA group

    Placebo group

    Arm 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

    Placebo drug 1 tablet tid for 6 months

    Outcomes

    Primary Outcome Measures

    Peritoneal membrane function
    Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test

    Secondary Outcome Measures

    Residula renal function
    Changes in estimated GFR
    Epithelial to Mesenchymal Transition, EMT
    Phenotypic changes of Mesothelial cells
    Oxydative stress
    Measurement of GSH/GSSG, 8-OHdG

    Full Information

    First Posted
    January 12, 2015
    Last Updated
    May 13, 2015
    Sponsor
    Ewha Womans University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02338635
    Brief Title
    Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis
    Official Title
    Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    January 2017 (Anticipated)
    Study Completion Date
    January 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ewha Womans University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End-Stage Kidney Disease
    Keywords
    ER stress, Peritoneal Dialysis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    55 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    URSA group
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo drug 1 tablet tid for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    Ursodeoxycholic Acid
    Other Intervention Name(s)
    URSA
    Intervention Description
    Inhibition of ER stress (Ursodeoxycholic Acid)
    Primary Outcome Measure Information:
    Title
    Peritoneal membrane function
    Description
    Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Residula renal function
    Description
    Changes in estimated GFR
    Time Frame
    6 months
    Title
    Epithelial to Mesenchymal Transition, EMT
    Description
    Phenotypic changes of Mesothelial cells
    Time Frame
    6 months
    Title
    Oxydative stress
    Description
    Measurement of GSH/GSSG, 8-OHdG
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mina Yu, MD
    Phone
    +82-10-5096-7285
    Email
    yuelizabeth@hanmail.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyun-Jung Kim, NR
    Email
    40739@eumc.co.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Duk-Hee Kang, MD. PhD.
    Organizational Affiliation
    Ewha Womans University Mokdong Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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