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

August 28, 2014 updated by: Astellas Pharma Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

267

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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, 50931
      • Koln, Germany, 51109
      • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: Tacrolimus
Immunosuppression
Active Comparator: 1
Drug: Tacrolimus
Immunosuppression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal function measured by creatinine clearance
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute rejection
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Europe B.V.

Investigators

  • Study Director: Medical Physician, Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506-02-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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