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

Completed · Phase 3

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT00064701

Run by

Astellas Pharma Inc

People needed

668

Starts

2003-06-01

Expected to finish

2009-03-01

Last updated by the study team

2013-12-05

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Loma Linda, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palo Alto, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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