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

NCT ID: NCT00296309

Last Updated: 2014-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-08-31

Brief Summary

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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.

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Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant

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Detailed Description

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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.

Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

Immunosuppression

2

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

Immunosuppression

Interventions

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Tacrolimus

Immunosuppression

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Physician

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

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Brussels, , Belgium

Site Status

Leuven, , Belgium

Site Status

Bordeaux, , France

Site Status

Clermont-Ferrand, , France

Site Status

Créteil, , France

Site Status

Le Kremlin-Bicêtre, , France

Site Status

Montpellier, , France

Site Status

Nice, , France

Site Status

Suresnes, , France

Site Status

Toulouse, , France

Site Status

Tours, , France

Site Status

Vandœuvre-lès-Nancy, , France

Site Status

Berlin, , Germany

Site Status

Cologne, , Germany

Site Status

Cologne, , Germany

Site Status

Essen, , Germany

Site Status

Freiberg, , Germany

Site Status

Halle, , Germany

Site Status

Hanover, , Germany

Site Status

Jena, , Germany

Site Status

Leipzig, , Germany

Site Status

Lübeck, , Germany

Site Status

München, , Germany

Site Status

Münster, , Germany

Site Status

Rostock, , Germany

Site Status

Utrecht, , Netherlands

Site Status

Madrid, , Spain

Site Status

Madrid, , Spain

Site Status

Santander, , Spain

Site Status

Zurich, , Switzerland

Site Status

Belfast, , United Kingdom

Site Status

Cambridge, , United Kingdom

Site Status

Nottingham, , United Kingdom

Site Status

Countries

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Belgium France Germany Netherlands Spain Switzerland United Kingdom

Related Links

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http://www.accessdata.fda.gov/scripts/cder/drugsatfda

Link to FDA Website

Other Identifiers

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FG-506-02-42

Identifier Type: -

Identifier Source: org_study_id

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