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

Kidney Transplantation Clinical Trial

— SENIOR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296309
• Other study ID #: FG-506-02-42
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2006
• Last updated: August 28, 2014
• Start date: October 2004
• Est. completion date: August 2006

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Tacrolimus
Immunosuppression

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function measured by creatinine clearance		6 months	No
Secondary	Acute rejection		6 months	No

External Links

•   Link to FDA Website
•   Link to Results on JAPIC - enter 140562 in the JapicCTI-RNo. field