Kidney TransplantationPhase 4OPTIMIZENCT02161237
Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation
A Phase 4 study testing Advagraf® in people with Kidney Transplantation, run by Astellas Pharma Inc at 2 sites in 2 countries.
Trial summary
Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Advagraf®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Jun 2014to 22 Dec 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage kidney disease and a suitable candidate for primary kidney transplantation or re-transplantation
- Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type
- Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. And, male subject of childbearing potential should agree to maintain effective birth control during the study
Who cannot join
- Receiving or having previously received an organ transplant other than a kidney
- Cold ischemia time of the donor kidney > 24 hours
- Receiving a graft from a non-heart-beating donor other than of Maastricht category 3
- Significant liver disease
- Receiving a graft from a hepatitis C or B positive donor
- Requiring on-going dosing with a systemic immunosuppressive drug prior to transplantation (e.g. for Lupus disease, FSGN etc) other than minimal levels of immunosuppressant following failure of a previous transplantation without nephrectomy
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- Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract mal absorption or active peptic ulcer
- Subject or donor known to be HIV positive
- Known allergy or intolerance to tacrolimus, macrolide antibiotics, steroids, lactose, basiliximab or MMF or any of the product excipient
- Subject has malignant tumor
- Currently participating in another clinical trial, and/or has taken an investigational drug within 12 weeks prior to the study
- Subject with a high immunological risk
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multi-center, Randomized, Open-label, Pilot and Exploratory Study Investigating Safety and Efficacy in OPTIMIZEd Dosing of Advagraf® Kidney Transplantation in Asia.
Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf® over 52 weeks after kidney transplantation will also be obtained.
- Conditions
- Kidney Transplantation
- Being tested
- Advagraf®
- Keywords
- Acute rejection, Advagraf, Renal function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advagraf®Drug
Also called FK506, tacrolimus
oral
| Study group | Role | What they receive |
|---|---|---|
| standard dose group | Experimental | Oral Receives: Drug: Advagraf® |
| optimized dose group | Experimental | Oral Receives: Drug: Advagraf® |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimated GFR
Measured: at Week-52 after transplantation
Secondary outcomes (10)
creatinine clearance
Measured: at Week-52 after transplantation
serum creatinine level
Measured: at Week-52 after transplantation
Number of graft survival
Measured: at Week-52 after transplantation
Subject survival
Measured: at Week-52 after transplantation
number of biopsy-proven acute rejection
Measured: at Week-52 after transplantation
Composite of graft loss, subject death and biopsy proven acute rejection
Measured: at Week-52 after transplantation
Time to the first acute rejection
Measured: up to Week-52 after transplantation
Time to the first steroid-resistant acute rejection
Measured: up to Week-52 after transplantation
Severity of biopsy proven acute rejection
Severity is evaluated using Banff '07 Criteria
Measured: up to Week-52 after transplantation
Safety assessed by the incidence of adverse events, vital signs and lab tests
Measured: for 52 weeks after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study start26 Jun 2014
- Primary completion22 Dec 2016
- Study completion22 Dec 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161237
- Sponsor's protocol ID
- 506-MA-1001
- Acronym
- OPTIMIZE
- Status last verified
- Oct 2024
- First submitted
- 9 Jun 2014
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label, Pilot and Exploratory Study Investigating Safety and Efficacy in OPTIMIZEd Dosing of Advagraf® Kidney Transplantation in Asia.
- ClinicalTrials.gov ID
- NCT02161237
- Acronym / sponsor ID
- OPTIMIZE / 506-MA-1001
- Conditions
- Kidney Transplantation
- Keywords
- Acute rejection, Advagraf, Renal function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2014 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 11 Jun 2014 (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.
Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf® over 52 weeks after kidney transplantation will also be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard dose group | Experimental | Drug: Advagraf®Oral |
| optimized dose group | Experimental | Drug: Advagraf®Oral |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- End stage kidney disease and a suitable candidate for primary kidney transplantation or re-transplantation
- Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type
- Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. And, male subject of childbearing potential should agree to maintain effective birth control during the study
Key exclusion criteria (12 listed)
- Receiving or having previously received an organ transplant other than a kidney
- Cold ischemia time of the donor kidney > 24 hours
- Receiving a graft from a non-heart-beating donor other than of Maastricht category 3
- Significant liver disease
- Receiving a graft from a hepatitis C or B positive donor
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 |
|---|---|---|
| Advagraf®Also: FK506, tacrolimusoral | Drug | optimized dose group, standard dose group |
Primary outcome
estimated GFR
Time frame: at Week-52 after transplantation
10 secondary outcomes
creatinine clearance
Time frame: at Week-52 after transplantation
serum creatinine level
Time frame: at Week-52 after transplantation
Number of graft survival
Time frame: at Week-52 after transplantation
Subject survival
Time frame: at Week-52 after transplantation
number of biopsy-proven acute rejection
Time frame: at Week-52 after transplantation
Composite of graft loss, subject death and biopsy proven acute rejection
Time frame: at Week-52 after transplantation
Time to the first acute rejection
Time frame: up to Week-52 after transplantation
Time to the first steroid-resistant acute rejection
Time frame: up to Week-52 after transplantation
Severity of biopsy proven acute rejection
Time frame: up to Week-52 after transplantation
Safety assessed by the incidence of adverse events, vital signs and lab tests
Time frame: for 52 weeks after transplantation
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 31 Oct 2024.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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 Inc
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Advagraf® in people with Kidney Transplantation, run by Astellas Pharma Inc at 2 sites in 2 countries.
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 12 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea, Taiwan. 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?
estimated GFR (time frame: at Week-52 after transplantation). 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 31 Oct 2024.