Chronic Allograft NephropathyPhase 3NCT01056835
Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy
A Phase 3 study testing prostaglandin I2 analogue in people with Chronic Allograft Nephropathy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the development of chronic allograft nephropathy and changes in allograft function in prevalent renal transplant recipients Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Chronic Allograft Nephropathy
- What is being tested?
- prostaglandin I2 analogue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Jun 2014
- Phase
- Phase 3
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- prevalent renal transplant recipients 2 years after transplantation
- no history of acute rejection
- stable renal function
Who cannot join
- history of biopsy-proven chronic allograft nephropathy
- history of biopsy-proven CNI nephrotoxicity
- history of biopsy-proven or clinical acute rejection
- unstable trough level of CNI or extremely low level of CNI
- bleeding tendency(+)
- pregnancy or pregnant-willing
Show all 9Show fewer
- anticoagulation(+)
- antiplatelet agent (+)
- significant comorbidity(+): Acute coronary syndrome, pneumonia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the development of chronic allograft nephropathy and changes in allograft function in prevalent renal transplant recipients
- Conditions
- Chronic Allograft Nephropathy
- Being tested
- prostaglandin I2 analogue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prostaglandin I2 analogueDrug
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described Receives: Drug: prostaglandin I2 analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft pathology, serum creatinine, creatinine clearance, eGFR
Measured: 1 year after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Allograft NephropathyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jongwon Ha, Seoul National University Hospital
- Investigators
- Jongwon Ha, MD, PhD, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056835
- Sponsor's protocol ID
- Beraprost-01
- Status last verified
- May 2015
- First submitted
- 24 Jan 2010
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PGI2 Analogue Use on the Development of Chronic Allograft Nephropathy
- ClinicalTrials.gov ID
- NCT01056835
- Acronym / sponsor ID
- Beraprost-01
- Conditions
- Chronic Allograft Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Jan 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.
The purpose of this study is to evaluate the effect of Prostaglandin I2 analogue use on the development of chronic allograft nephropathy and changes in allograft function in prevalent renal transplant recipients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | Drug: prostaglandin I2 analogue |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- prevalent renal transplant recipients 2 years after transplantation
- no history of acute rejection
- stable renal function
Key exclusion criteria (9 listed)
- history of biopsy-proven chronic allograft nephropathy
- history of biopsy-proven CNI nephrotoxicity
- history of biopsy-proven or clinical acute rejection
- unstable trough level of CNI or extremely low level of CNI
- bleeding tendency(+)
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 |
|---|---|---|
| prostaglandin I2 analogue | Drug | control |
Primary outcome
graft pathology, serum creatinine, creatinine clearance, eGFR
Time frame: 1 year after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
Jongwon Ha, MD, PhD principal investigator
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prostaglandin I2 analogue in people with Chronic Allograft Nephropathy, run by Seoul National University Hospital 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 27 May 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft pathology, serum creatinine, creatinine clearance, eGFR (time frame: 1 year after drug administration). 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 May 2015.