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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296309
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : September 1, 2014
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Tacrolimus Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : October 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Active Comparator: 1 Drug: Tacrolimus

Experimental: 2 Drug: Tacrolimus

Primary Outcome Measures :
  1. Renal function measured by creatinine clearance [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Acute rejection [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00296309

Bruxelles, Belgium, 1200
Leuven, Belgium, 3000
Bordeaux, France, 33076
Clermont Ferrand, France, 63003
Creteil, France, 94010
Le Kremlin Bicetre, France, 94275
Montpellier, France, 34295
Nice, France, 06002
Suresnes, France, 92151
Toulouse, France, 31059
Tours, France, 37044
Vandoeuvre les Nancy, France, 54511
Berlin, Germany, 10117
Essen, Germany, 45122
Freiberg, Germany, 79106
Halle, Germany, 06120
Hannover, Germany, 30625
Jena, Germany, 07747
Koln, Germany, 50931
Koln, Germany, 51109
Leipzig, Germany, 04103
Lubeck, Germany, 23562
Munchen, Germany, 81675
Munster, Germany, 48149
Rostock, Germany, 18057
Utrecht, Netherlands, 3508
Madrid, Spain, 28007
Madrid, Spain, 28041
Santander, Spain, 39008
Zurich, Switzerland, 8091
United Kingdom
Belfast, United Kingdom, BT9 7AB
Cambridge, United Kingdom, CB2 2QQ
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe B.V.
Study Director: Medical Physician Astellas Pharma Europe B.V.

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00296309     History of Changes
Other Study ID Numbers: FG-506-02-42
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc:
Kidney Transplantation
Treatment Outcomes

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action