NCT02554955

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

Pilot, Single-arm, Non-comparative, Open-label Study of Daclizumab in Combination With Mycophenolate Mofetil and Sirolimus in the Prevention of Acute Rejection in Cardiac Allografts Recipients in Risk of Deteriorated Renal Function

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Transplantation

Interventions

Type	Name	Description
DRUG	Daclizumab	Participants will receive IV daclizumab (2 mg/kg within 6 hours after transplantation and 1 mg/kg every 2 weeks) for a total of five doses.
DRUG	Mycophenolate mofetil	Participants will receive mycophenolate mofetil orally (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg BID within first week and 1 g/day BID from second week onwards) for 6 months.
DRUG	Silrolimus	Participants will receive sirolimus orally (3 mg/day) for 6 months.

Timeline

• Start date: 2004-02-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2015-09-18
• Last updated: 2016-11-02

Locations

14 sites across 1 country: Spain