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

NCT02338635 | Unknown Phase 4

• 1 other identifier: URSA-1
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End-Stage Kidney Disease

Keywords

ER stress; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• Peritoneal membrane function

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

  6 months

Secondary Outcomes (3)

• Residula renal function

  6 months

• Epithelial to Mesenchymal Transition, EMT

  6 months

• Oxydative stress

  6 months

Study Arms (2)

URSA group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

Placebo drug 1 tablet tid for 6 months

Interventions

Ursodeoxycholic Acid DRUG

Inhibition of ER stress (Ursodeoxycholic Acid)

Also known as: URSA

URSA group

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Duk-Hee Kang, MD. PhD.

  Ewha Womans University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mina Yu, MD

CONTACT

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

Hyun-Jung Kim, NR

CONTACT

40739@eumc.co.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 14, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2018
• Last Updated: May 15, 2015

Record last verified: 2015-05