Clinical trial NCT00064701: Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: De Novo Kidney Transplant
cyclosporine
Prograf®
mycophenolate mofetil
tacrolimus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2003-07-14
Enrollment: 668
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This was a 3 arm randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients at 60 centers in the U.S., Canada and Brazil.

The study consisted of a 1-year post-transplant efficacy and safety study with a clinical continuation phase of a minimum of 2 years or until commercial availability of tacrolimus modified release, unless the Data Safety Monitoring Board or sponsor specified otherwise.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Efficacy Failure
timeFrame: one year
Secondary outcomes:
measure: Patient Survival at One Year
timeFrame: One year
measure: Graft Survival at One Year
timeFrame: One year
measure: Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months
timeFrame: Six months and 12 months
measure: Time to First Biopsy-confirmed Acute Rejection Episode
timeFrame: one year
measure: Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection
timeFrame: one year
measure: Severity of Acute Rejection
timeFrame: one year
measure: Number of Participants Experiencing Multiple Rejection Episodes
timeFrame: one year
measure: Number of Participants With Clinically Treated Acute Rejection Episodes
timeFrame: one year
measure: Number of Participants With Treatment Failure
timeFrame: one year
measure: Number of Participants Who Crossed Over Due to Treatment Failure
timeFrame: one year
measure: Change From Month 1 in Serum Creatinine at Month 6 and Month 12
timeFrame: Month 1, Month 6, and Month 12
measure: Change From Month 1 in Creatinine Clearance at Month 6 and Month 12
timeFrame: Month 1, Month 6, and Month 12
measure: Kaplan-Meier Estimate of Patient Survival at the End of the Study
timeFrame: End of study (maximum time on study was 1,941 days).
measure: Kaplan-Meier Estimate of Graft Survival at the End of the Study
timeFrame: End of study (maximum time on study was 1,941 days).
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Livingston
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Harrisburg
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Fairfax
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Porto Alegre
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Silva HT Jr, Yang HC, Abouljoud M, Kuo PC, Wisemandle K, Bhattacharya P, Dhadda S, Holman J, Fitzsimmons W, First MR. One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients. Am J Transplant. 2007 Mar;7(3):595-608. doi: 10.1111/j.1600-6143.2007.01661.x. Epub 2007 Jan 11.