End-Stage Kidney DiseasePhase 4NCT01111422
Anti-Oxidant Effect on Peritoneal Membrane in Peritoneal Dialysis (PD) Patients
A Phase 4 study testing N-acetylcysteine in people with End-Stage Kidney Disease and Peritoneal Dialysis, run by Ewha Womans University at 1 site in South Korea.
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 reactive oxygen species may be responsible for progressive membrane dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- End-Stage Kidney Disease, Peritoneal Dialysis
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to Dec 2011
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- 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 N-acetylcysteine
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ewha Womans University Mokdong Hospital
Seoul
Mina Yu, MD, +82-2-2650-2562, yuelizabeth@hanmail.net
Hyun Jung Kim, Nurse, +82-2-2650-5497
About this study
Official title: A Randomized Prospective Trial of N-acetyl Cystein in Patients With Peritoneal Dialysis
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 reactive oxygen species may be responsible for progressive membrane dysfunction. N-acetylcysteine (NAC)is a powerful antioxidant shown to protect peritoneal fibrosis in peritoneal dialysis animal model. In this study the researchers investigated the hypothesis that NAC protect peritoneal membrane damage.
Read the detailed description
N-Acetylcysteine (NAC) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 1200 mg per day. Patients will be randomly assigned to NAC and control 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, Peritoneal Dialysis
- Being tested
- N-acetylcysteine
- Keywords
- Antioxidant, Epithelial to Mesenchymal Transition, peritoneal fibrosis, Peritoneal Dialysis, Continuous Ambulatory
- Medical subject headings
- Kidney Failure, Chronic, Peritoneal Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Also called Muteran capsuleⓇ HAN WHA PHARM.
N-acetylcysteine (200 mg/capsule) 1200 mg/day (600 mg bid) for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Age and sex matched peritoneal dialysis patients |
| N-acetylcysteine | Experimental | N-acetylcysteine in stable peritoneal dialysis patients Receives: Drug: N-acetylcysteine |
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 (4)
Oxydative stress status
Measurement of oxydative stress status with plasma and RBC (GSH/GSSG, 8-OHdG)
Measured: 6 months
Mesothelial cell transformation (Epithelial to Mesenchymal Transition)
Morphology was analysed with peritoneal dialysate isolated mesothelial cell
Measured: 6 month
Residual renal function
Changes in residual renal function (ΔKt/Vurea, ΔeGFR)
Measured: 6 month
Peritoneal membrane function
Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (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
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Investigators
- Duk-Hee Kang, MD. PhD., Principal investigator, Ewha Womans University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111422
- Sponsor's protocol ID
- Ewha 219-3-40
- Status last verified
- Mar 2010
- First submitted
- 23 Apr 2010
- Last updated
- 27 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Trial of N-acetyl Cystein in Patients With Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT01111422
- Acronym / sponsor ID
- Ewha 219-3-40
- Conditions
- End-Stage Kidney Disease, Peritoneal Dialysis
- Keywords
- Antioxidant, Epithelial to Mesenchymal Transition, peritoneal fibrosis, Peritoneal Dialysis, Continuous Ambulatory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 27 Apr 2010 (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 reactive oxygen species may be responsible for progressive membrane dysfunction. N-acetylcysteine (NAC)is a powerful antioxidant shown to protect peritoneal fibrosis in peritoneal dialysis animal model. In this study the researchers investigated the hypothesis that NAC protect peritoneal membrane damage.
Detailed description
N-Acetylcysteine (NAC) is known to be relatively safe and beneficial in peritoneal dialysis patient at a dose of 1200 mg per day. Patients will be randomly assigned to NAC and control 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Age and sex matched peritoneal dialysis patients |
| N-acetylcysteine | Experimental | Drug: N-acetylcysteineN-acetylcysteine in stable peritoneal dialysis patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 (4 listed)
- Episode of peritonitis at least 3 months
- Episodes of admission due to other disease at lease 3 months
- Liver disease
- Allergic history with N-acetylcysteine
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 |
|---|---|---|
| N-acetylcysteineAlso: Muteran capsuleⓇ HAN WHA PHARM.N-acetylcysteine (200 mg/capsule) 1200 mg/day (600 mg bid) for 6 months | Drug | N-acetylcysteine |
Primary outcome
Peritoneal membrane function
Time frame: 6 months
Changes in peritoneal membrane function (Δ D/Pcreatinine, ΔD/Purea) with peritoneal equilibrium test
4 secondary outcomes
Oxydative stress status
Time frame: 6 months
Mesothelial cell transformation (Epithelial to Mesenchymal Transition)
Time frame: 6 month
Residual renal function
Time frame: 6 month
Peritoneal membrane function
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
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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.
Duk-Hee Kang, MD. PhD. principal investigator
Ewha Womans University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-acetylcysteine in people with End-Stage Kidney Disease and Peritoneal Dialysis, run by Ewha Womans University at 1 site in South Korea.
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 4 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 27 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 (+82-2-2650-2562, 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 27 Apr 2010.