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

Phase 3

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Tacrolimus

• Registration Number: NCT00296309
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-10
• Study First Submitted: 2006-02-23
• Study First Submitted QC: 2006-02-23
• Study First Posted: 2006-02-27
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Tacrolimus	-
2	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Renal function measured by creatinine clearance	6 months

Secondary Outcome Measures

Name	Time	Method
Acute rejection	6 months