A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants

Phase 4

Completed

• Conditions: Heart Transplantation
• Interventions: Drug: Daclizumab; Drug: Mycophenolate mofetil; Drug: Silrolimus

• Registration Number: NCT02554955
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function. The anticipated time on study treatment is 6 months, and the target sample size is 44 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Adult participants greater than 18 years of age
• Single organ (heart) transplant recipients
• At risk for post-transplant renal dysfunction

Exclusion Criteria

• Previous organ transplant
• Previous treatment with mycophenolate mofetil, daclizumab or sirolimus
• Positive for human immunodeficiency virus (HIV) infection
• History of malignancy within the last 5 years, except localized and treated skin cancer, treated and without evident relapse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daclizumab + Mycophenolate mofetil	Silrolimus	Participants will receive intravenous (IV) daclizumab (2 milligrams per kilogram \[mg/kg\] within 6 hours after transplantation and 1 mg/kg every 2 weeks for a total of five doses), along with mycophenolate mofetil (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg twice daily \[BID\] within first week and 1 grams per day \[g/day\] BID from second week onwards) and sirolimus (3 mg/day) for 6 months.
Daclizumab + Mycophenolate mofetil	Daclizumab	Participants will receive intravenous (IV) daclizumab (2 milligrams per kilogram \[mg/kg\] within 6 hours after transplantation and 1 mg/kg every 2 weeks for a total of five doses), along with mycophenolate mofetil (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg twice daily \[BID\] within first week and 1 grams per day \[g/day\] BID from second week onwards) and sirolimus (3 mg/day) for 6 months.
Daclizumab + Mycophenolate mofetil	Mycophenolate mofetil	Participants will receive intravenous (IV) daclizumab (2 milligrams per kilogram \[mg/kg\] within 6 hours after transplantation and 1 mg/kg every 2 weeks for a total of five doses), along with mycophenolate mofetil (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg twice daily \[BID\] within first week and 1 grams per day \[g/day\] BID from second week onwards) and sirolimus (3 mg/day) for 6 months.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with reported biopsy proven acute rejection episodes	up to 6 months

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	up to 6 months
Incidence of Opportunistic Infections	Up to 5 years post transplant
Patient and graft survival	up to 6 months
Number of participants with malignancies	up to 6 months