Clinical trial NCT00189839: A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation
Official title: A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Tacrolimus
Kidney transplantation
Transplantation, kidney
Renal Transplantation
Transplantation, renal
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 699
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

Detailed description: A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen.

Eligibility criteria: Inclusion Criteria:

* Patients receiving a kidney transplant from a cadaveric donor or a living non HLA identical donor between 5 and 65 years of age with compatible ABO blood type.
* Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or re-transplantation (unless the graft was lost because of immunological reasons within 12 months).

Exclusion Criteria:

* Patients receiving or having previously received an organ transplant other than a kidney.
* Patients with a high immunological risk, defined as a panel reactive antibodies (PRA) grade \>50% in the previous 6 months and/or with a previous graft survival of less than 12 months due to immunological reasons.
* Cold ischaemia time of the donor kidney \>30 hours.

Primary outcomes:
measure: Time to and incidence of biopsy-proven acute rejections
timeFrame: 12 months
Secondary outcomes:
measure: Overall rate of acute rejections
timeFrame: 12 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Santa Fe
country: Argentina
city: Melbourne
country: Australia
city: Sydney
country: Australia
city: Westmead
country: Australia
city: Woudville South
country: Australia
city: Innsbruck
country: Austria
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Campinas - SP
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio de Janeiro - RJ
country: Brazil
city: San Paulo - SP
country: Brazil
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Praha 4
country: Czech Republic
city: Helsinki
country: Finland
city: Creteil
country: France
city: Grenoble
country: France
city: Le Kremlin Bicetre Cedex
country: France
city: Lille Cedex
country: France
city: Montpellier Cedex 05
country: France
city: Nantes Cedex 01
country: France
city: Nice Cedex 1
country: France
city: Saint-Etienne
country: France
city: Toulouse Cedex 9
country: France
city: Vandoeuvre les Nancy Cedex
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Erlangen
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Halle
country: Germany
city: Hann
country: Germany
city: Koln
country: Germany
city: Munchen
country: Germany
city: Regensburg
country: Germany
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Dublin
country: Ireland
city: Bari
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Pisa
country: Italy
city: Siena
country: Italy
city: Treviso
country: Italy
city: Cuernavaca Morelos
country: Mexico
city: Mexico D.F.
country: Mexico
city: Maastricht
country: Netherlands
city: Utrecht
country: Netherlands
city: Oslo
country: Norway
city: Bydgoszcz
country: Poland
city: Szczecin
country: Poland
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Pretoria
country: South Africa
city: Badalona Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: La Coruna
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Goteborg
country: Sweden
city: Uppsala
country: Sweden
city: Zurich
country: Switzerland
city: Belfast
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Coventry
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Klinikum der Universität Regensburg
name: B Krämer
role: PRINCIPAL_INVESTIGATOR
References:
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.