Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.

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

Details

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

Criteria

Inclusion Criteria:

• Recipient of a primary or retransplanted non-human leukocyte antigen (HLA)-identical living or non-HLA-identical cadaveric kidney transplant

• Age greater or equal to 12 years

Exclusion Criteria:

• Recipient or donor is known seropositive for human immunodeficiency virus (HIV)

• Has current malignancy or history of malignancy

• Has significant liver disease

• Has uncontrolled concomitant infection or any other unstable medical condition

• Is receiving everolimus or enteric coated mycophenolic acid at any time during the study

• Received kidney with a cold ischemia time of equal or more than 36 hours

• Received kidney transplant from a cadaveric donor equal or more than 60 years of age

• Received intravenous immunoglobulin (IVIG) therapy prior to randomization