Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.

Last updated: August 28, 2014
Sponsor: Astellas Pharma Inc
Overall Status: Completed

Phase

3

Condition

Kidney Transplantation

Treatment

N/A

Clinical Study ID

NCT00296309
FG-506-02-42
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with minimum 60 years of age and end stage kidney disease who are suitablecandidates for primary renal transplantation or retransplantation are eligible for thestudy. Patients receiving a kidney transplant, from a cadaveric or living donor (notHLA identical) with compatible ABO blood type can be included.

Exclusion

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

Study Design

Total Participants: 267
Study Start date:
October 01, 2004
Estimated Completion Date:
August 31, 2006

Study 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.

Connect with a study center

  • Bruxelles, 1200
    Belgium

    Site Not Available

  • Leuven, 3000
    Belgium

    Site Not Available

  • Bordeaux, 33076
    France

    Site Not Available

  • Clermont Ferrand, 63003
    France

    Site Not Available

  • Creteil, 94010
    France

    Site Not Available

  • Le Kremlin Bicetre, 94275
    France

    Site Not Available

  • Montpellier, 34295
    France

    Site Not Available

  • Nice, 06002
    France

    Site Not Available

  • Suresnes, 92151
    France

    Site Not Available

  • Toulouse, 31059
    France

    Site Not Available

  • Tours, 37044
    France

    Site Not Available

  • Vandoeuvre les Nancy, 54511
    France

    Site Not Available

  • Berlin, 10117
    Germany

    Site Not Available

  • Essen, 45122
    Germany

    Site Not Available

  • Freiberg, 79106
    Germany

    Site Not Available

  • Halle, 06120
    Germany

    Site Not Available

  • Hannover, 30625
    Germany

    Site Not Available

  • Jena, 07747
    Germany

    Site Not Available

  • Koln, 50931
    Germany

    Site Not Available

  • Leipzig, 04103
    Germany

    Site Not Available

  • Lubeck, 23562
    Germany

    Site Not Available

  • Munchen, 81675
    Germany

    Site Not Available

  • Munster, 48149
    Germany

    Site Not Available

  • Rostock, 18057
    Germany

    Site Not Available

  • Utrecht, 3508
    Netherlands

    Site Not Available

  • Madrid, 28041
    Spain

    Site Not Available

  • Santander, 39008
    Spain

    Site Not Available

  • Zurich, 8091
    Switzerland

    Site Not Available

  • Belfast, BT9 7AB
    United Kingdom

    Site Not Available

  • Cambridge, CB2 2QQ
    United Kingdom

    Site Not Available

  • Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.