End-Stage Kidney DiseasePhase 4NCT02338635
Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis
A Phase 4 study testing Ursodeoxycholic Acid in people with End-Stage Kidney Disease, run by Ewha Womans University.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- End-Stage Kidney Disease
- What is being tested?
- Ursodeoxycholic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Hyun-Jung Kim, NR contact
About this study
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.
Read the 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.
- Conditions
- End-Stage Kidney Disease
- Being tested
- Ursodeoxycholic Acid
- Keywords
- ER stress, Peritoneal Dialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic AcidDrug
Also called URSA
Inhibition of ER stress (Ursodeoxycholic Acid)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ursodeoxycholic Acid |
| Placebo group | Placebo comparator | Placebo drug 1 tablet tid for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal membrane function
Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test
Measured: 6 months
Secondary outcomes (3)
Residula renal function
Changes in estimated GFR
Measured: 6 months
Epithelial to Mesenchymal Transition, EMT
Phenotypic changes of Mesothelial cells
Measured: 6 months
Oxydative stress
Measurement of GSH/GSSG, 8-OHdG
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duk-Hee Kang, Ewha Womans University
- Investigators
- Duk-Hee Kang, MD. PhD., Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338635
- Sponsor's protocol ID
- URSA-1
- Status last verified
- May 2015
- First submitted
- 12 Jan 2015
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ursodeoxycholic Acid on Peritoneal Function in Patients on Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT02338635
- Acronym / sponsor ID
- URSA-1
- Conditions
- End-Stage Kidney Disease
- Keywords
- ER stress, Peritoneal Dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| URSA group | Experimental | Drug: Ursodeoxycholic AcidDrug: 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 group | Placebo comparator | –Placebo drug 1 tablet tid for 6 months |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursodeoxycholic AcidAlso: URSAInhibition of ER stress (Ursodeoxycholic Acid) | Drug | URSA group |
Primary outcome
Peritoneal membrane function
Time frame: 6 months
Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test
3 secondary outcomes
Residula renal function
Time frame: 6 months
Epithelial to Mesenchymal Transition, EMT
Time frame: 6 months
Oxydative stress
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun-Jung Kim, NR contact
Duk-Hee Kang, MD. PhD. principal investigator
Ewha Womans University Mokdong Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ursodeoxycholic Acid in people with End-Stage Kidney Disease, run by Ewha Womans University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Yu, MD (+82-10-5096-7285, yuelizabeth@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal membrane function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2015.