Clinical trial NCT00296361: To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.
Official title: A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination Therapy of Tacrolimus With Sirolimus Versus Tacrolimus With Mycophenolate Mofetil in Kidney Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Tacrolimus
Kidney Transplantation
Immunosuppression
Adult
Treatment Outcomes
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-02-27
Enrollment: 634
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.

Detailed description: This phase III study shall provide detailed efficacy and safety information to compare this combination of sirolimus and tacrolimus with the current standard tacrolimus combination regimen (tacrolimus/MMF/steroids) which is widely used in European centres.

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 60 years of age and having end stage kidney disease who will undergo primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible AB0 blood type can be included.

Exclusion Criteria:

* Patient has a high immunological risk
* Cold ischemia time greater than 30 hours
* Patient has significant liver disease
* Patient has severe hypercholesterolaemia
* Patient is allergic or intolerant to study medication
* Patient requires ongoing dosing with corticosteroids.
* Patient or donor is known to be HIV positive
* Patient with malignancy or history of malignancy

Primary outcomes:
measure: Renal function as assessed by calculated creatinine clearance at month 6.
timeFrame: 6 months
Secondary outcomes:
measure: Acute rejection: Incidence of and time to first acute rejection
timeFrame: 6 months
Other outcomes:
Locations:
city: Nedlands
country: Australia
city: Perth
country: Australia
city: Linz
country: Austria
city: Linz
country: Austria
city: Wien
country: Austria
city: Brussels
country: Belgium
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Olomouc
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Amiens
country: France
city: Brest
country: France
city: Dijon
country: France
city: Limoges
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Toulouse
country: France
city: Aachen
country: Germany
city: Bochum
country: Germany
city: Freiburg
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Hann. Münden
country: Germany
city: Hannover
country: Germany
city: Koln
country: Germany
city: Koln
country: Germany
city: Munster
country: Germany
city: Regensburg
country: Germany
city: Rostock
country: Germany
city: Debrecen
country: Hungary
city: Milano
country: Italy
city: Napoli
country: Italy
city: Rotterdam
country: Netherlands
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Bucharest
country: Romania
city: Alicante
country: Spain
city: Badalona-Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cadiz
country: Spain
city: Cordoba
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Palma de Mallorca
country: Spain
city: Santander
country: Spain
city: Santiago de Compostela
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Goteborg
country: Sweden
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Physician
role: STUDY_DIRECTOR
References: