Clinical trial NCT00048165: A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation
Official title: A Double-Blind, Placebo -Controlled, Randomized Study to Assess the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2002-10-25
Enrollment: 434
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the number of randomized participants in each treatment group who experience an acute rejection episode in the first 6 months after undergoing cardiac transplantation.


Eligibility criteria: Inclusion Criteria:

* Participants must be undergoing their first cardiac allograft transplant
* Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to transplantation
* Women of childbearing potential must use two reliable forms of contraception simultaneously. Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy
* Participants and/or their guardians must be willing and be capable of understanding risks and comply with the purpose of the study

Exclusion Criteria:

* Previous organ transplants
* Participants receiving multiple organs
* Participants requiring ventricular assist device (VAD) upon completion of transplantation surgery
* Women lactating, pregnant or of childbearing potential not using, or who are unwilling to use two reliable forms of contraception simultaneously during the study
* History of a psychological illness or condition which would interfere with the participant's ability to understand the requirements of the study
* White blood count =\<2500/mm\^3, platelets =\<50,000/mm\^3 or hemoglobin =\<6 g/dL
* HIV-1, the presence of positive HBsAg, or chronic active hepatitis C
* Active peptic ulcer disease
* Severe diarrhea or other gastrointestinal disorders which might interfere with their ability to absorb oral medication
* Malignancies within the past 5 years, excluding skin carcinoma that have been adequately treated
* Participants who have received within the past 30 days or require concomitant treatment with other investigational drugs or immunosuppressive medications that are prohibited for this study
* Inability to start microemulsion form of cyclosporine within 72 hours

Primary outcomes:
measure: Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant
timeFrame: Up to 6 months PT
Secondary outcomes:
measure: Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT
timeFrame: Up to 12 months PT
measure: Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT
timeFrame: Within 6 months and 12 months PT
measure: Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT
timeFrame: At 6 months, 12 months , 3 years PT
measure: Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT
timeFrame: Within 6 months and 12 months PT
measure: Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT
timeFrame: Within 6 months and 12 months PT
measure: Number of Participants Using Monomurab Cluster of Differentiation 3, Orthoclone Polyclonal Antithymocyte Globulin or Antilymphocyte Globulin in the First 6 Months and 12 Months PT
timeFrame: Within 6 months and 12 months PT
measure: Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT
timeFrame: Within 6 months and 12 months PT
measure: Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides)
timeFrame: From Baseline (Day -2) to 3 months and 6 months
measure: Median Change From Baseline for LDL/HDL Ratio
timeFrame: From Baseline (Day -2) to 3 months, and 6 months
measure: Number of Participants With Marked Laboratory Abnormalities: Hematology Parameters
timeFrame: Up to 12 months
measure: Number of Participants With Marked Laboratory Abnormalities: Biochemistry Parameters
timeFrame: Up to 12 months
measure: Number of Participants With Any Adverse Events and Any Serious Adverse Event, and Adverse Events Leading to Premature Withdrawal
timeFrame: Up to 12 months
measure: Number of Participants With Malignancies and Opportunistic Infections
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Frankfurt Am Main
country: Germany
city: Hannover
country: Germany
city: Goeteborg
country: Sweden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: