A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation

Heart Transplantation Clinical Trial

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 Transplatation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048165
• Other study ID #: NR15880
• Status: Completed
• Phase: Phase 4
• First received: October 24, 2002
• Last updated: March 21, 2016
• Start date: August 1999
• Est. completion date: August 2002

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: August 2002
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Drug:
• Daclizumab
Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50.
• Methylprednisolone
Methylprednisolone will be administered as 500-1000 mg IV and peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering till 0.0-0.15 mg/kg/day (up to 365 days).
• Mycophenolate mofetil
Mycophenolate mofetil will be administered as 1.5 grams bid begun post-op, either IV or orally as required up to 365 days.
• Placebo
Matching placebo will be administered on Days 1, 8, 22, 36, and 50.
• cyclosporine
Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who developed acute rejection episode within the first 6 months following transplantation		Up to 6 months	No
Secondary	Number of participants with marked laboratory abnormalities		Up to 12 months	No
Secondary	Number of participants who developed acute rejection episode within the 12 months following transplantation		Up to 12 months	No
Secondary	Number of acute rejection episodes per participant within the first 6 months and within the first 12 months post-transplantation		Up to 12 months	No
Secondary	Participant and graft survival at 6 months, at 12 months, and at 3 years post transplantation		At 6 months, 12 months, and 3 years	No
Secondary	Participants With Worst International Society of Heart and Lung Transplant (ISHLT) biopsy grade in the first 6 months and within the first 12 months post-transplantation		Up to 12 months	No
Secondary	Time to first acute rejection episode within the first 6 months and within the first 12 months		Up to 12 months	No
Secondary	Use of Monomunab CD3, Orthoclone (OKT3) or Antithymocyte globulin (ATGAM) in the first 6 months post-transplantation		Up to 6 months	No
Secondary	Maintenance doses of CellCept and cyclosporine, and cumulative dose of corticosteroids at 6 and 12 months post-transplantation		At 6 and 12 months	No
Secondary	Change from baseline for lipid profile		Baseline (Day 1), 3 months, and 6 months	No
Secondary	Number of participants with adverse events, malignancies, opportunistic infections, and premature withdrawal due to adverse events		Up to 12 months	No