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
About this trial
This is an interventional treatment trial for End-Stage Kidney Disease focused on measuring ER stress, Peritoneal Dialysis
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
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
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
Learn more about this trial
Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis
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