Kidney TransplantationPhase 2/3NCT01476488
Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients
A Phase 2/3 study testing tacrolimus in people with Kidney Transplantation and Pediatric Patients, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients. Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Kidney Transplantation, Pediatric Patients, Maintenance With Tacrolimus
- What is being tested?
- tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Mar 2013
- Phase
- Phase 2/3
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ABO-compatible kidney-only transplantation
- more than 1 year after kidney transplantation
- 5 to 15 years old
- patients maintained on Prograf
- tacrolimus level of determined previously: 4 to 20 ng/ml
- eGFR by Schwartz equation > 50mL/min
Who cannot join
- patients with acute rejection within 90 days
- patients with acute rejection requiring antibody therapy within 6 months
- patients with more than 2 times of acute rejection within 1 year
- AST/ALT 2 times more than upper normal limit
- ABO-incompatible or crossmatch-positive transplantation
- multiorgan transplantation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: Conversion of Twice-a-day Tacrolimus to Once-Daily Tacrolimus Extended-Release Formulation in Stable Pediatric Kidney Transplant Recipients
This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients.
Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. The patients will have another pharmacokinetic study of tacrolimus after conversion to advagraf.
- Being tested
- tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called Prograf, Advagraf
| Study group | Role | What they receive |
|---|---|---|
| Advagraf | No intervention | single group, conversion of prograf to advagraf Receives: Drug: tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve of tacrolimus pharmacokinetics (AUC0-24)
The investigator will compare the changes in AUC0-24 of tacrolimus, Cmax, Tmax and correlation between C0 and Cmax
Secondary outcomes (1)
Number of Participants with Adverse Event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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 College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476488
- Sponsor's protocol ID
- Adva01SNUH
- Status last verified
- May 2015
- First submitted
- 22 Jul 2011
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
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
- Conversion of Twice-a-day Tacrolimus to Once-Daily Tacrolimus Extended-Release Formulation in Stable Pediatric Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT01476488
- Acronym / sponsor ID
- Adva01SNUH
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (actual)
- First posted
- 22 Nov 2011 (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.
This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients.
Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. The patients will have another pharmacokinetic study of tacrolimus after conversion to advagraf.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advagraf | No intervention | Drug: tacrolimussingle group, conversion of prograf to advagraf |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- ABO-compatible kidney-only transplantation
- more than 1 year after kidney transplantation
- 5 to 15 years old
- patients maintained on Prograf
- tacrolimus level of determined previously: 4 to 20 ng/ml
Key exclusion criteria (6 listed)
- patients with acute rejection within 90 days
- patients with acute rejection requiring antibody therapy within 6 months
- patients with more than 2 times of acute rejection within 1 year
- AST/ALT 2 times more than upper normal limit
- ABO-incompatible or crossmatch-positive transplantation
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 |
|---|---|---|
| tacrolimusAlso: Prograf, Advagraf | Drug | Advagraf |
Primary outcome
Area Under the Curve of tacrolimus pharmacokinetics (AUC0-24)
The investigator will compare the changes in AUC0-24 of tacrolimus, Cmax, Tmax and correlation between C0 and Cmax
1 secondary outcome
Number of Participants with Adverse Event
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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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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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 College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing tacrolimus in people with Kidney Transplantation and Pediatric Patients, 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 6 inclusion and 6 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Area Under the Curve of tacrolimus pharmacokinetics (AUC0-24). 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.