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

Condition(s) targeted: Kidney Transplantation

Intervention: Tacrolimus Modified Release (MR) (Drug); Tacrolimus (Drug); cyclosporine microemulsion (Drug); mycophenolate mofetil (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 1 yr Efficacy Failure (composite endpoint defined as death, graft loss, having biopsy confirmed acute rejection or lost-to follow up)

Secondary outcome:

1 year patient and graft survival rates

Incidence of biopsy confirmed acute rejection (Banff Grade ≥ 1) at 6 and 12 months, time to first acute rejection episode,

Requirement of anti-lymphocyte antibody therapy for treatment of rejection

Severity of acute rejection

Number of patients experiencing multiple rejection episodes

Number of clinically treated acute rejection episodes

Incidence of crossover for treatment failure,Evaluation of renal function.

Detailed description: 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.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

Birmingham, Alabama 35294, United States

Mobile, Alabama 36617, United States

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Palo Alto, California 94304, United States

San Diego, California 92103, United States

Los Angeles, California 90033, United States

Los Angeles, California 90057, United States

Loma Linda, California 92354, United States

San Francisco, California 94115, United States

Los Angeles, California 90058, United States

Los Angeles, California 90095-7306, United States

San Diego, California 92123, United States

Denver, Colorado 80262, United States

Washington, District of Columbia 20010, United States

Jacksonville, Florida 32216, United States

Gainesville, Florida 32610-0224, United States

Augusta, Georgia 30912, United States

Chicago, Illinois 60637, United States

Chicago, Illinois 60612, United States

Indianapolis, Indiana 46202, United States

Lexington, Kentucky 40536, United States

New Orleans, Louisiana 70121, United States

New Orleans, Louisiana 70112, United States

Boston, Massachusetts 02214, United States

Detroit, Michigan 48202, United States

Ann Arbor, Michigan 48109-0364, United States

New Brunswick, New Jersey 08901, United States

Livingston, New Jersey 07039, United States

New York, New York 10029, United States

Valhalla, New York 10595, United States

Albany, New York 12208, United States

Buffalo, New York 14203, United States

Chapel Hill, North Carolina 27599-7211, United States

Durham, North Carolina 27710, United States

Cincinnati, Ohio 45267, United States

Toronto, Ontario, Canada

Portland, Oregon 97210, United States

Portland, Oregon 97239-2940, United States

Philadelphia, Pennsylvania 19104, United States

Philadelphia, Pennsylvania 19107, United States

Harrisburg, Pennsylvania 17104, United States

Montreal, Quebec, Canada

Nashville, Tennessee 37212-4750, United States

Dallas, Texas 75235, United States

Dallas, Texas 75246, United States

San Antonio, Texas 78229-3900, United States

Houston, Texas 77030, United States

Salt Lake City, Utah 84132, United States

Fairfax, Virginia 22031, United States

Milwaukee, Wisconsin 53226, United States

Madison, Wisconsin 53792-7375, United States

Starting date: June 2003
Ending date: December 2008
Last updated: December 20, 2007