Phase 4
N=434
A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation
Heart Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00048165 ↗Enrolled (actual)
434
Serious AEs
49.7%
Results posted
Jun 2016
Primary outcome: Primary: Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant — 77; 104 participants — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Daclizumab (Drug); Methylprednisolone (Drug); Mycophenolate mofetil (Drug); Placebo (Drug); cyclosporine (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2002
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant |
77; 104 | 0.007 sig |
| SECONDARY Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT |
97; 116 | 0.063 |
| SECONDARY Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT |
139; 114; 63; 82; 12; 19 | — |
| SECONDARY Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT |
16; 10; 21; 12; NA; NA | — |
| SECONDARY Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT |
9; 5; 64; 51; 26; 28 | 0.0005 sig |
| SECONDARY Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT |
61; 21; 96; 26 | — |
| SECONDARY 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 |
17; 19; 23; 21 | — |
| SECONDARY Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT |
2522.2; 2450; 2394.1; 2380.1; 86.11; 38.1 | — |
| SECONDARY Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides) |
0.65; 0.91; 0.28; 0.61; 0.25; 0.34 | — |
| SECONDARY Median Change From Baseline for LDL/HDL Ratio |
-0.44; -0.12; -0.50; -0.14 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities: Hematology Parameters |
0; 0; 116; 117; 0; 0 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities: Biochemistry Parameters |
48; 45; 15; 7; 22; 25 | — |
| SECONDARY Number of Participants With Any Adverse Events and Any Serious Adverse Event, and Adverse Events Leading to Premature Withdrawal |
214; 207; 108; 102; 14; 11 | — |
| SECONDARY Number of Participants With Malignancies and Opportunistic Infections |
11; 11; 71; 80 | — |
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
Data sourced from ClinicalTrials.gov (NCT00048165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.