Clinical trial NCT00087581: Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation
Official title: An Open-Label, Prospective, Randomized, Controlled, Multi-Center Study Assessing Fixed Dose Versus Concentration Controlled Cellcept® Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-07-14
Enrollment: 720
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have undergone kidney transplantation. Participants will be randomized to one of three dosing regimens to receive concentration-controlled MMF with reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard CNI. Participants will be followed for 20-24 months after randomization.


Eligibility criteria: Inclusion Criteria:

* Males or females 13-75 years of age
* Single organ recipient (kidney only) from living (related or unrelated) or cadaveric heart-beating donors
* Receiving first or second kidney transplant

Exclusion Criteria:

* Immunosuppressive therapy (except for 48 hours prior to transplantation and corticosteroid treatment) within previous 28 days for a first transplant and 3 months for a second transplant
* History of malignancy in last 5 years (except successfully treated localized non-melanoma skin cancer)

Primary outcomes:
measure: Percentage of Participants with Treatment Failure During 12 Months Post-Transplantation
timeFrame: Month 12
measure: Percent Change from Baseline in Calculated Glomerular Filtration Rate (GFR) at 12 Months Post-Transplantation
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Percentage of Participants with Treatment Failure During 6 and 20-24 Months Post-Transplantation
timeFrame: Months 6, 20-24
measure: Percentage of Participants with Biopsy-Proven Acute Rejection (BPAR)
timeFrame: Months 6, 12, 20-24
measure: Percentage of Participants by Number of BPAR Episodes
timeFrame: Months 6, 12, 20-24
measure: Percentage of Participants Treated for Acute Rejection (AR)
timeFrame: Months 6, 12, 20-24
measure: Percentage of Participants Who Experienced Graft Loss
timeFrame: Months 6, 12, 20-24
measure: Percentage of Participants Who Died
timeFrame: Months 6, 12, 20-24
measure: Percentage of Participants Who Discontinued Treatment with MMF
timeFrame: Months 6, 12, 20-24
measure: Time to First BPAR Episode
timeFrame: Months 6, 12, 20-24
measure: Time to Treatment Failure
timeFrame: Months 6, 12, 20-24
measure: Percent Change from Baseline in Calculated GFR at 3, 6, and 20-24 Months Post-Transplantation
timeFrame: Baseline to Months 3, 6, 20-24
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Hackensack
country: United States
state: New Jersey
city: Livingston
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: Hawthorne
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Harrisburg
country: United States
state: Pennsylvania
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Falls Church
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: