Acute Rejection of Renal TransplantNCT01592253
Study to Evaluate Safety and Immunologic Biomarker of Rapamune in Patients With Stable Renal Transplant Recipient
A study testing Sirolimus in people with Acute Rejection of Renal Transplant, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
For patients who meet the inclusion criteria and who agree to participate in this study, the investigators sampled peripheral blood 10cc and performed the analysis for immunologic profile just before the conversion of immune suppressant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Rejection of Renal Transplant
- What is being tested?
- Sirolimus
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Dec 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Renal transplant recipient who has passed at least 10 years
- No acute rejection episode during the previous 6 months
- No change of prescription of immune suppressants
- Normal allograft function (MDRD eGFR > 80 mL/min/1.73 m2)
- Change of allograft function less than 10 % of baseline value durant the previous 1 year
- No proteinuria and hematuria
Who cannot join
- Patients who donut want to participate in this study
- Patients who should continue immune suppressant due to another cause (e/g combined autoimmune disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Safety and Immunologic Biomarker After Conversion From Calcineurin Inhibitor to Rapamune in Stable Renal Transplant Recipient
For patients who meet the inclusion criteria and who agree to participate in this study, the investigators sampled peripheral blood 10cc and performed the analysis for immunologic profile just before the conversion of immune suppressant. At 1 month, 6 month, and 1 year from the conversion of Immune suppressant (CNI to rapamune), the investigators performed tha analysis fo immune profile again. During the study period, the interval of the visit of subclinic and the kinds of laboratory test (Blood and urine test) would not change compared to before the start of this study.
- Conditions
- Acute Rejection of Renal Transplant
- Being tested
- Sirolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Beginning on day, an initial maintenance dose of 2mg/day should be given. A trough level should be obtained between days 3 and 8, and the daily dose of sirolimus should be adjusted thereafter.
What is being measured
The primary outcome is the main question the study is designed to answer.
biopsy proven acute rejection
Number of episode of biopsy proven acute rejection
Measured: Study duration is 12 months
Secondary outcomes (1)
Serum Creatinine, MDRD eGFR
Mean diurnal Serum Creatinine, MDRD eGFR change of greater than or equal to 20% at month 12 vs baseline
Measured: Study duration is 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Rejection of Renal TransplantStudies 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChulWoo Yang, Seoul St. Mary's Hospital
- Investigators
- ChulWoo Yang, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592253
- Sponsor's protocol ID
- RAPA CONVERT TRIAL
- Status last verified
- Jun 2012
- First submitted
- 3 May 2012
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Safety and Immunologic Biomarker After Conversion From Calcineurin Inhibitor to Rapamune in Stable Renal Transplant Recipient
- ClinicalTrials.gov ID
- NCT01592253
- Acronym / sponsor ID
- RAPA CONVERT TRIAL
- Conditions
- Acute Rejection of Renal Transplant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 May 2012 (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.
For patients who meet the inclusion criteria and who agree to participate in this study, the investigators sampled peripheral blood 10cc and performed the analysis for immunologic profile just before the conversion of immune suppressant. At 1 month, 6 month, and 1 year from the conversion of Immune suppressant (CNI to rapamune), the investigators performed tha analysis fo immune profile again. During the study period, the interval of the visit of subclinic and the kinds of laboratory test (Blood and urine test) would not change compared to before the start of this study.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Renal transplant recipient who has passed at least 10 years
- No acute rejection episode during the previous 6 months
- No change of prescription of immune suppressants
- Normal allograft function (MDRD eGFR > 80 mL/min/1.73 m2)
- Change of allograft function less than 10 % of baseline value durant the previous 1 year
Key exclusion criteria (2 listed)
- Patients who donut want to participate in this study
- Patients who should continue immune suppressant due to another cause (e/g combined autoimmune disease)
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 |
|---|---|---|
| SirolimusBeginning on day, an initial maintenance dose of 2mg/day should be given. A trough level should be obtained between days 3 and 8, and the daily dose of sirolimus should be adjusted thereafter. | Drug | – |
Primary outcome
biopsy proven acute rejection
Time frame: Study duration is 12 months
Number of episode of biopsy proven acute rejection
1 secondary outcome
Serum Creatinine, MDRD eGFR
Time frame: Study duration is 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
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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.
ChulWoo Yang principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sirolimus in people with Acute Rejection of Renal Transplant, run by Seoul St. Mary's 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 6 inclusion and 2 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 25 Jun 2012. 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.
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 Byung Ha Chung, Assistant professor (82-2-2258-6066, chungbh@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biopsy proven acute rejection (time frame: Study duration is 12 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 25 Jun 2012.