Kidney TransplantationPhase 4OSAKANCT00717470
A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection
A Phase 4 study testing Prograf®, Advagraf® and Mycophenolate Mofetil in people with Kidney Transplantation, run by Astellas Pharma Inc at 110 sites in 22 countries.
Trial summary
To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Prograf®, Advagraf® and Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,252 participants
- Where
- 110 sitesin 22 countries
- Study dates
- 14 May 2008to 2 Mar 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
- Receiving a kidney transplant from a cadaveric or living (non HLA identical) 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
Who cannot join
- Receiving or having previously received an organ transplant other than a kidney
- Cold ischemia time of the donor kidney > 30 hours
- Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
- Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
- Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
- Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
Show all 13Show fewer
- Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
- Pregnant woman or breast-feeding mother
- Subject or donor known to be HIV positive
- Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
- Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully
- Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
- Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
Trial locations and contacts
110 sites in 22 countries.
110 sites in 22 countries
France20 sites
Study site
Angers, 49033
Study site
Bordeaux, 33076
Study site
Brest, 29609
Study site
Créteil, 94010
Study site
La Tronche, 38700
Study site
Le Kremlin-Bicêtre, 94275
Study site
Limoges, 87042
Study site
Lyon, 69437
Study site
Nantes, 44035
Study site
Nice, 06002
Study site
Paris, 75743
Study site
Paris, 75908
Study site
Paris, 75970
Study site
Rennes, 35033
Study site
Saint-Etienne, 42055
Study site
Strasbourg, 67091
Study site
Suresnes, 92151
Study site
Toulouse, 31054
Study site
Tours, 37044
Study site
Vandœuvre-lès-Nancy, 54511
Spain20 sites
Study site
A Coruña, 15006
Study site
Albacete, 02006
Study site
Alicante, 03010
Study site
Barakaldo-Vizcaya, 48903
Study site
Barcelona, 08035
Study site
Barcelona, 08907
Study site
Cadiz, 11009
Study site
Granada, 18012
Study site
Madrid, 28007
Study site
Madrid, 28034
Study site
Madrid, 28046
Study site
Murcia, 30120
Study site
Oviedo, 33006
Study site
Palma de Mallorca, 07014
Study site
Pamplona, 31080
Study site
Salamanca, 37007
Study site
Seville, 41013
Study site
Valencia, 46009
Study site
Valencia, 46017
Study site
Zaragoza, 50009
Germany17 sites
Study site
Aachen, 52074
Study site
Berlin, 13353
Study site
Essen, 45147
Study site
Frankfurt, 60590
Study site
Freiburg I. Br, 79106
Study site
Halle, 06120
Study site
Hamburg, 20251
Study site
Hanover, 30625
Study site
Jena, 07747
Study site
Kaiserslautern, 67655
Study site
Kiel, 24105
Study site
Leipzig, 04103
Study site
München, 81675
Study site
Münster, 48149
Study site
Regensburg, 93042
Study site
Rostock, 18057
Study site
Tübingen, 72076
Italy7 sites
Study site
Ancona, 60020
Study site
Bologna, 40138
Study site
Milan, 20162
Study site
Padova, 35128
Study site
Roma, 00144
Study site
Siena, 53100
Study site
Treviso, 31100
Poland6 sites
Study site
Bialystok, 15-540
Study site
Gdansk, 80-211
Study site
Lublin, 20-090
Study site
Poznan, 60-479
Study site
Warsaw, 022-006
Study site
Wroclaw, 50-419
Russia5 sites
Study site
Moscow, 123182
Study site
Moscow, 129090
Study site
Omsk, 644112
Study site
Saint Petersburg, 197110
Study site
Volgograd, 404120
Belgium4 sites
Study site
Brussels, 1070
Study site
Brussels, 1200
Study site
Ghent, 9000
Study site
Leuven, 3000
Czechia4 sites
Study site
Brno, 65691
Study site
Hradec Kravlove, 50005
Study site
Ostrava, 70852
Study site
Prague, 14021
United Kingdom4 sites
Study site
Birmingham, B15 2TH
Study site
Glasgow, G11 6NT
Study site
Leicester, LE54PW
Study site
Manchester, M13 9WL
Austria3 sites
Study site
Innsbruck, A-6020
Study site
Linz, A-4010
Study site
Vienna, A-1090
Argentina2 sites
Study site
Buenos Aires, C1425FAB
Study site
Córdoba, X5016KEH
South Africa2 sites
Study site
Cape Town, 7925
Study site
Johannesburg, 2193
About this study
Official title: A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)
To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus
- Conditions
- Kidney Transplantation
- Being tested
- Prograf®, Advagraf®, Mycophenolate Mofetil, Simulect, methylprednisolone / prednisone
- Keywords
- Kidney, Prograf, Transplant, Advagraf, Immunosuppression, FK506
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prograf®Drug
Also called FK506, Tacrolimus
oral
Advagraf®Drug
Also called MR4, FK506XL, Tacrolimus extended release
oral
Also called MMF
oral
SimulectDrug
Also called basiliximab
oral
methylprednisolone / prednisoneDrug
Also called corticosteroids
oral
| Study group | Role | What they receive |
|---|---|---|
| Prograf + MMF + Steroids | Active comparator | oral Receives: Drug: Prograf®; Drug: Mycophenolate Mofetil; Drug: methylprednisolone / prednisone |
| Advagraf (dose 1) + MMF + steroids | Active comparator | oral Receives: Drug: Advagraf®; Drug: Mycophenolate Mofetil; Drug: methylprednisolone / prednisone |
| Advagraf (dose 2) + MMF + steroids | Active comparator | oral Receives: Drug: Advagraf®; Drug: Mycophenolate Mofetil; Drug: methylprednisolone / prednisone |
| Advagraf + MMF + Basilixmab + steroids | Active comparator | oral Receives: Drug: Advagraf®; Drug: Mycophenolate Mofetil; Drug: Simulect; Drug: methylprednisolone / prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy failure rate
Measured: 24 weeks
Secondary outcomes (1)
Renal Function, acute rejection, Biopsy confirmed acute rejection
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study start14 May 2008
- Primary completion2 Mar 2010
- Study completion2 Mar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717470
- Sponsor's protocol ID
- PMR-EC-1210
- Other IDs
- 2007-005376-13
- Acronym
- OSAKA
- Status last verified
- Oct 2024
- First submitted
- 16 Jul 2008
- Last updated
- 1 Nov 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/.
Publications
Albano L, Banas B, Klempnauer JL, Glyda M, Viklicky O, Kamar N; Optimising immunoSuppression After Kidney transplantation with ADVAGRAF Study Group. OSAKA trial: a randomized, controlled trial comparing tacrolimus QD and BD in kidney transplantation. Transplantation. 2013 Nov 27;96(10):897-903. doi: 10.1097/TP.0b013e3182a203bd.
PubMed 23982340Kramer BK, Albano L, Banas B, Charpentier B, Backman L, Tedesco-Silva H Jr, Lehner F, Mondragon-Ramirez GA, Glyda M, Cassuto-Viguier E, Viklicky O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.
PubMed 29149958
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)
- ClinicalTrials.gov ID
- NCT00717470
- Acronym / sponsor ID
- OSAKA / PMR-EC-1210
- Conditions
- Kidney Transplantation
- Keywords
- Kidney, Prograf, Transplant, Advagraf, Immunosuppression, FK506
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,252 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 14 May 2008 (actual)
- Primary completion
- 2 Mar 2010 (actual)
- Study completion
- 2 Mar 2010 (actual)
- First posted
- 17 Jul 2008 (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.
To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prograf + MMF + Steroids | Active comparator | Drug: Prograf®, Drug: Mycophenolate Mofetil, Drug: methylprednisolone / prednisoneoral |
| Advagraf (dose 1) + MMF + steroids | Active comparator | Drug: Advagraf®, Drug: Mycophenolate Mofetil, Drug: methylprednisolone / prednisoneoral |
| Advagraf (dose 2) + MMF + steroids | Active comparator | Drug: Advagraf®, Drug: Mycophenolate Mofetil, Drug: methylprednisolone / prednisoneoral |
| Advagraf + MMF + Basilixmab + steroids | Active comparator | Drug: Advagraf®, Drug: Mycophenolate Mofetil, Drug: Simulect, Drug: methylprednisolone / prednisoneoral |
Who may qualify
- Ages
- 18 years and older
- 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 renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
- Receiving a kidney transplant from a cadaveric or living (non HLA identical) 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
Key exclusion criteria (13 listed)
- Receiving or having previously received an organ transplant other than a kidney
- Cold ischemia time of the donor kidney > 30 hours
- Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
- Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
- Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
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 |
|---|---|---|
| Prograf®Also: FK506, Tacrolimusoral | Drug | Prograf + MMF + Steroids |
| Advagraf®Also: MR4, FK506XL, Tacrolimus extended releaseoral | Drug | Advagraf (dose 1) + MMF + steroids, Advagraf (dose 2) + MMF + steroids, Advagraf + MMF + Basilixmab + steroids |
| Mycophenolate MofetilAlso: MMForal | Drug | Advagraf (dose 1) + MMF + steroids, Advagraf (dose 2) + MMF + steroids, Advagraf + MMF + Basilixmab + steroids, Prograf + MMF + Steroids |
| SimulectAlso: basiliximaboral | Drug | Advagraf + MMF + Basilixmab + steroids |
| methylprednisolone / prednisoneAlso: corticosteroidsoral | Drug | Advagraf (dose 1) + MMF + steroids, Advagraf (dose 2) + MMF + steroids, Advagraf + MMF + Basilixmab + steroids, Prograf + MMF + Steroids |
Primary outcome
Efficacy failure rate
Time frame: 24 weeks
1 secondary outcome
Renal Function, acute rejection, Biopsy confirmed acute rejection
Time frame: 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 Nov 2024.
- Background: PubMed 23982340Albano L, Banas B, Klempnauer JL, Glyda M, Viklicky O, Kamar N; Optimising immunoSuppression After Kidney transplantation with ADVAGRAF Study Group. OSAKA trial: a randomized, controlled trial comparing tacrolimus QD and BD in kidney transplantation. Transplantation. 2013 Nov 27;96(10):897-903. doi: 10.1097/TP.0b013e3182a203bd.
- Derived from this study: PubMed 29149958Kramer BK, Albano L, Banas B, Charpentier B, Backman L, Tedesco-Silva H Jr, Lehner F, Mondragon-Ramirez GA, Glyda M, Cassuto-Viguier E, Viklicky O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.
- 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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Hypothermic Kidney Machine Perfusion With Omnisol
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Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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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.
Central Contact study chair
Astellas Pharma Europe B.V.
110 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prograf®, Advagraf® and Mycophenolate Mofetil in people with Kidney Transplantation, run by Astellas Pharma Inc at 110 sites in 22 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 13 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 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in France, Spain, Germany, Italy, Poland and 17 more countries. 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?
Efficacy failure rate (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00717470, which also lists 2 linked publications.
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 Nov 2024.