Clinical trial NCT00296309: Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.
Official title: A Multicentre, Randomised, Open Clinical Study to Compare the Efficacy and Safety of a Combination of Tacrolimus and Mycophenolate Mofetil Based Regimen With or Without Induction in Elderly Recipients Undergoing 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
Collaborators: name: Astellas Pharma Europe B.V.
First posted: 2006-02-27
Enrollment: 267
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary objective of this study is to compare the renal function as well as the incidence of renal dysfunction, the incidence of death, graft loss and acute rejection. Secondary Objective is to compare the efficacy and safety profiles of the two regimens in elderly renal transplanted patients.

Detailed description: The use of tacrolimus-based primary immunosuppression in elderly renal transplant recipients is efficacious and safe, particularly in combination with MMF, and seems to be associated with lower mortality and graft loss rates than classic cyclosporin protocols. Nevertheless, the efficacy and safety of tacrolimus in monotherapy, double or triple therapy with MMF, as well as the induction therapy with the new anti-IL2 receptor antibodies have not been adequately used in controlled trials in the elderly renal transplant patient. There is only scarce information on age-associated immune responsiveness and only a few aged-adapted immunosuppressive regimens have been described.

Eligibility criteria: Inclusion Criteria:

* Patients with minimum 60 years of age and end stage kidney disease who are suitable candidates for 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 ABO blood type can be included.

Exclusion Criteria:

* Patient has an immunological high risk
* Cold ischemia time greater than 30 hours.
* Patient has significant liver disease
* Patient is allergic or intolerant to study medication
* Patient or donor is known to be HIV positive.
* Patient with malignancy or history of malignancy
* Patient has significant, uncontrolled concomitant infections

Primary outcomes:
measure: Renal function measured by creatinine clearance
timeFrame: 6 months
Secondary outcomes:
measure: Acute rejection
timeFrame: 6 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Bordeaux
country: France
city: Clermont Ferrand
country: France
city: Creteil
country: France
city: Le Kremlin Bicetre
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Suresnes
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Vandoeuvre les Nancy
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Freiberg
country: Germany
city: Halle
country: Germany
city: Hannover
country: Germany
city: Jena
country: Germany
city: Koln
country: Germany
city: Koln
country: Germany
city: Leipzig
country: Germany
city: Lubeck
country: Germany
city: Munchen
country: Germany
city: Munster
country: Germany
city: Rostock
country: Germany
city: Utrecht
country: Netherlands
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Santander
country: Spain
city: Zurich
country: Switzerland
city: Belfast
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Physician
role: STUDY_DIRECTOR
References: