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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02338635

Enrollment

Registered

2015-01-14

Start date

2015-07-31

Completion date

2018-01-31

Last updated

2015-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Kidney Disease

Keywords

ER stress, Peritoneal Dialysis

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.

Interventions

DRUGUrsodeoxycholic Acid

Inhibition of ER stress (Ursodeoxycholic Acid)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactMina Yu, MD

yuelizabeth@hanmail.net+82-10-5096-7285

Backup ContactHyun-Jung Kim, NR

40739@eumc.co.kr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026