Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the safety and efficacy of two different immunosuppressive regimens (sequential tacrolimus/mycophenolate mofetil [MMF] plus steroids versus tacrolimus plus MMF, following induction with daclizumab) in recipients of marginal donor kidneys.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• Male or female patients minimum 60 years of age undergoing a cadaveric kidney transplant

• Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation.

• Donors older than 60 years

• Female patients of child bearing age agree to practice effective birth control during the study.

• Patient has been fully informed and has given written informed consent

Exclusion Criteria:

• Patient has significant, uncontrolled, concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer

• Patient has previously received or is receiving an organ transplant other than kidney or a kidney retransplant

• Any pathology or medical condition that can interfere with this protocol study proposal

• Other exclusion criteria apply