Kidney TransplantationPhase 4PeACENCT01839929
A Study to Assess the Safety and Efficacy of ADVAGRAF (Tacrolimus Modified Release Formulation) in Kidney Transplant Patients Who Were Treated With PROGRAF
A Phase 4 study testing Prograf and Advagraf in people with Kidney Transplantation, run by Astellas Pharma Korea, Inc. at 4 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy of tacrolimus modified release formulation Advagraf® after conversion from Prograf® in stable kidney transplant patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Prograf and Advagraf
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Sep 2010to Feb 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients received a kidney transplant at least 12 months ago prior to enrollment.
- Patients have taken unchanged dosage of Prograf® and remained stable serum level of tacrolimus at least for 12 weeks prior to enrollment.
- Patients have kept in unchanged immunosuppressive therapy (combination therapy) at least for 12 weeks prior to enrollment.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial.
- Patients are considered clinically stable by observer's judgment.
- Patients must understand the purpose and risk of participating the trial and signed on the written consent.
Who cannot join
- Patients have previously received an organ transplant other than a kidney.
- Patients have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
- Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted.
- Patients have a known hypersensitivity to Prograf® or tacrolimus.
- Patients whose medical condition are able to interfere with the study objectives.
- Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer.
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- Patients have been participated in another clinical trial, or treated with drugs of clinical trial within 28 days prior to enrollment.
- Patients have been taken prohibited combination agents within 28 days prior to enrollment.
- Patients are pregnant or lactating.
- Patient are HIV-positive.
- Patients are not able to keep the scheduled visit.
- Patients whose GFR (MDRD) is in the level of <30 mL/min.
- Patients who are at the condition of 'Creeping creatinine (defined by 20% increase within 6 months prior to enrollment)
- Patients whose SGPT/AST and/or SGOT/ALT levels have been elevated greater than 2 times the upper value of the normal range.
- Patients have FSGS or MPGN Type II as underlying diseases.
- Patients are with cirrhosis
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Study site
Busan
Study site
Daegu
Study site
Daejeon
Study site
Seoul
About this study
Official title: A Multicenter, Open-label, Single-arm, Non-inferiority Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF® in Stable Kidney Transplant Patients Converted From a PROGRAF® Based Immunosuppressive Regimen
The purpose of this study is to evaluate the efficacy of tacrolimus modified release formulation Advagraf® after conversion from Prograf® in stable kidney transplant patients.
- Conditions
- Kidney Transplantation
- Being tested
- Prograf, Advagraf
- Keywords
- tacrolimus, immunosuppressant, FK506
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrografDrug
Also called FK506, tacrolimus
oral
AdvagrafDrug
Also called FK506E, tacrolimus modified release formulation
oral
| Study group | Role | What they receive |
|---|---|---|
| Prograf/Advagraf | Experimental | conversion from Prograf to Advagraf Receives: Drug: Prograf; Drug: Advagraf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glomerular filtration rate (GFR) at Week 24 from baseline
Measured: Baseline and Week-24
Secondary outcomes (5)
Change in Blood Pressure (BP) at Week 24 from baseline
Measured: Baseline and Week-24
Change in HbA1c at Week 24 from baseline
Measured: Baseline and Week-24
Change in tacrolimus blood trough level at Week 24 from baseline
Measured: Baseline and Week-24
Safety assessed by the incidence of adverse events, physical exam., vital signs and labo tests
Measured: For 24 weeks
Overall frequency of acute rejection
Measured: For 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startSep 2010
- Primary completionFeb 2013
- Study completionFeb 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Korea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Korea, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839929
- Sponsor's protocol ID
- ADV-KT-02
- Acronym
- PeACE
- Status last verified
- Apr 2013
- First submitted
- 23 Apr 2013
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, Non-inferiority Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF® in Stable Kidney Transplant Patients Converted From a PROGRAF® Based Immunosuppressive Regimen
- ClinicalTrials.gov ID
- NCT01839929
- Acronym / sponsor ID
- PeACE / ADV-KT-02
- Conditions
- Kidney Transplantation
- Keywords
- tacrolimus, immunosuppressant, FK506
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Apr 2013 (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 efficacy of tacrolimus modified release formulation Advagraf® after conversion from Prograf® in stable kidney transplant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prograf/Advagraf | Experimental | Drug: Prograf, Drug: Advagrafconversion from Prograf to Advagraf |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients received a kidney transplant at least 12 months ago prior to enrollment.
- Patients have taken unchanged dosage of Prograf® and remained stable serum level of tacrolimus at least for 12 weeks prior to enrollment.
- Patients have kept in unchanged immunosuppressive therapy (combination therapy) at least for 12 weeks prior to enrollment.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial.
- Patients are considered clinically stable by observer's judgment.
Key exclusion criteria (16 listed)
- Patients have previously received an organ transplant other than a kidney.
- Patients have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
- Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted.
- Patients have a known hypersensitivity to Prograf® or tacrolimus.
- Patients whose medical condition are able to interfere with the study objectives.
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 |
|---|---|---|
| PrografAlso: FK506, tacrolimusoral | Drug | Prograf/Advagraf |
| AdvagrafAlso: FK506E, tacrolimus modified release formulationoral | Drug | Prograf/Advagraf |
Primary outcome
Change in glomerular filtration rate (GFR) at Week 24 from baseline
Time frame: Baseline and Week-24
5 secondary outcomes
Change in Blood Pressure (BP) at Week 24 from baseline
Time frame: Baseline and Week-24
Change in HbA1c at Week 24 from baseline
Time frame: Baseline and Week-24
Change in tacrolimus blood trough level at Week 24 from baseline
Time frame: Baseline and Week-24
Safety assessed by the incidence of adverse events, physical exam., vital signs and labo tests
Time frame: For 24 weeks
Overall frequency of acute rejection
Time frame: For 24 weeks
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 1 May 2013.
Related trials for Kidney Transplantation
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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.
Medical Director study director
Astellas Pharma Korea, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prograf and Advagraf in people with Kidney Transplantation, run by Astellas Pharma Korea, Inc. at 4 sites 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 16 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 1 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Change in glomerular filtration rate (GFR) at Week 24 from baseline (time frame: Baseline and Week-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 1 May 2013.