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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00296309
First received: February 23, 2006
Last updated: August 28, 2014
Last verified: August 2014

February 23, 2006
August 28, 2014
October 2004
August 2006   (final data collection date for primary outcome measure)
Renal function measured by creatinine clearance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00296309 on ClinicalTrials.gov Archive Site
Acute rejection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Transplantation
Drug: Tacrolimus
Immunosuppression
  • Active Comparator: 1
    Intervention: Drug: Tacrolimus
  • Experimental: 2
    Intervention: Drug: Tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
267
August 2006
August 2006   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Belgium,   France,   United Kingdom,   Netherlands,   Spain,   Switzerland
 
NCT00296309
FG-506-02-42
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Astellas Pharma Europe B.V.
Study Director: Medical Physician Astellas Pharma Europe B.V.
Astellas Pharma Inc
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP