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



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

For Condition: Kidney Transplantation
Status: No longer recruiting
Sponsor(s): Fujisawa Healthcare, Inc. ,
Synopsis: 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.
Details: This will be a 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.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 660

Location and Contact Information:


Additional Information:
Study ID Numbers:
  02-0-158; 
Study Start Date: June 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064701

Other Kidney Transplantation Studies:
1. A Study To Test An Anti-Rejection Therapy After Kidney Transplantation

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

3. Kidney and Liver Transplantation in People with HIV

4. A Study of the Safety and Effectiveness of Varivax (the Chicken Pox Vaccine) in Children Who Have Received Kidney Transplants

5. TThe Role of Connective Tissue Growth Factor in the Development of Kidney Disease After Organ Transplantation

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

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