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
  Purpose

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 Intervention Phase
Kidney Transplantation
Drug: Tacrolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Renal function measured by creatinine clearance [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute rejection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 267
Study Start Date: October 2004
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Tacrolimus
Immunosuppression
Experimental: 2 Drug: Tacrolimus
Immunosuppression

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296309

Locations
Belgium
Bruxelles, Belgium, 1200
Leuven, Belgium, 3000
France
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
Germany
Berlin, Germany, 10117
Essen, Germany, 45122
Freiberg, Germany, 79106
Halle, Germany, 06120
Hannover, Germany, 30625
Jena, Germany, 07747
Koln, Germany, 51109
Koln, Germany, 50931
Leipzig, Germany, 04103
Lubeck, Germany, 23562
Munchen, Germany, 81675
Munster, Germany, 48149
Rostock, Germany, 18057
Netherlands
Utrecht, Netherlands, 3508
Spain
Madrid, Spain, 28041
Madrid, Spain, 28007
Santander, Spain, 39008
Switzerland
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.
Investigators
Study Director: Medical Physician Astellas Pharma Europe B.V.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00296309     History of Changes
Other Study ID Numbers: FG-506-02-42
Study First Received: February 23, 2006
Last Updated: August 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Astellas Pharma Inc:
Tacrolimus
Kidney Transplantation
Immunosuppression
Adult
Treatment Outcomes

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014