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

Official Title: “A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF, Modified Release (MR) Tacrolimus/MMF and Neoral (Cyclosporine)/MMF in de Novo Kidney Transplant Recipients”

The purpose of this study is to compare the safety and efficacy of Prograf/MMF, Neoral/MMF and Modified Release (MR) Tacrolimus/MMF in de novo kidney transplant recipients.

This will be a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients. Enrollment will include approximately 660 patients at 60-70 centers in the U.S., Canada and South America.

Intervention(s) in this Clinical Trial

• Drug: Tacrolimus Modified Release (MR)
  • Oral
• Drug: Tacrolimus
  • Oral
• Drug: cyclosporine microemulsion
  • Oral
• Drug: mycophenolate mofetil
  • Oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2
  • tacrolimus
• Active Comparator: 3
  • CsA

Primary Measures

• 1 yr Efficacy Failure (composite endpoint defined as death, graft loss, having biopsy confirmed acute rejection or lost-to follow up)
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• 1 year patient and graft survival rates
  • Time Frame: Annually and End of Study
    Safety Issue?: No
• Incidence of biopsy confirmed acute rejection (Banff Grade ≥ 1) at 6 and 12 months, time to first acute rejection episode,
  • Time Frame: Annually and End of Study
    Safety Issue?: No
• Requirement of anti-lymphocyte antibody therapy for treatment of rejection
  • Time Frame: Annually and End of Study
    Safety Issue?: No
• Severity of acute rejection
  • Time Frame: Annually and End of Study
    Safety Issue?: No
• Number of patients experiencing multiple rejection episodes
  • Time Frame: Annually and End of Study
    Safety Issue?: No
• Number of clinically treated acute rejection episodes
  • Time Frame: Annually and End of Study
    Safety Issue?: No
• Incidence of crossover for treatment failure,Evaluation of renal function.
  • Time Frame: Annually and End of Study
    Safety Issue?: No

Inclusion Criteria:

• Recipient of a primary or retransplanted non-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 IVIG therapy prior to randomization

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Astellas Pharma Inc Industry

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Director Astellas Pharma Global Development  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00064701

Study ID Number: 02-0-158

ClinicalTrials.gov Identifier: NCT00064701

Health Authority: United States: Food and Drug Administration