Clinical trial NCT00717470: A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Kidney
Prograf
Transplant
Advagraf
Immunosuppression
FK506
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 1252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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* Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)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.
* 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

Primary outcomes:
measure: Efficacy failure rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Renal Function, acute rejection, Biopsy confirmed acute rejection
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Wien
country: Austria
city: Brussels
country: Belgium
city: Brussels
country: Belgium
city: Ghent
country: Belgium
city: Leuven
country: Belgium
city: Brno
country: Czechia
city: Hradec Kravlove
country: Czechia
city: Ostrava
country: Czechia
city: Prague
country: Czechia
city: Angers Cedex 01
country: France
city: Bordeaux
country: France
city: Brest Cedex 2
country: France
city: Creteil Cedex
country: France
city: La Tronche
country: France
city: Le Kremlin Bicetre Cedex
country: France
city: Limoges Cedex 1
country: France
city: Lyon Cedex 3
country: France
city: Nantes
country: France
city: Nice Cedex
country: France
city: Paris Cedex 15
country: France
city: Paris Cedex 20
country: France
city: Paris Cedex
country: France
city: Rennes Cedex 9
country: France
city: St. Etienne
country: France
city: Strasbourg Cedex
country: France
city: Suresnes Cedex
country: France
city: Toulouse Cedex
country: France
city: Tours Cedex 9
country: France
city: Vandoeuvre
country: France
city: Aachen
country: Germany
city: Berlin
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Freiburg I. Br
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Jena
country: Germany
city: Kaiserslautern
country: Germany
city: Kiel
country: Germany
city: Leipzig
country: Germany
city: Munchen
country: Germany
city: Munster
country: Germany
city: Regensburg
country: Germany
city: Rostock
country: Germany
city: Tubingen
country: Germany
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Szeged
country: Hungary
city: Dublin
country: Ireland
city: Ancona
country: Italy
city: Bologna
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Treviso
country: Italy
city: Maastricht
country: Netherlands
city: Oslo
country: Norway
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Warsaw
country: Poland
city: Wroclaw
country: Poland
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Bucharest
country: Romania
city: Cluj Napoca
country: Romania
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Omsk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Banska Bysterica
country: Slovakia
city: Kosice
country: Slovakia
city: Cape Town
country: South Africa
city: Johannesburg
country: South Africa
city: A Coruna
country: Spain
city: Albacete
country: Spain
city: Alicante
country: Spain
city: Barakaldo-Vizcaya
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cadiz
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Oviedo
country: Spain
city: Palma de Mallorca
country: Spain
city: Pamplona
country: Spain
city: Salamanca
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Zurich
country: Switzerland
city: Birmingham
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Leicester
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_CHAIR
References:
citation: 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.
citation: Kramer 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.