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

Heart Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554955
• Other study ID #: ML17910
• Status: Completed
• Phase: Phase 4
• First received: September 17, 2015
• Last updated: November 1, 2016
• Start date: February 2004
• Est. completion date: December 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Country: SpainEthics committees from the hospitals involved : Clinic, J Canalejo, C U de Navarra, 12 de Octubre,C. S. Bellvitge,Arrixaca,C de Asturias, Puerta de Hierro, Santa Creu i Sant Pau, Marqués de Valdecilla, HU de Valladolid,Virgen del Rocio
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

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.
• 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.
• Silrolimus
Participants will receive sirolimus orally (3 mg/day) for 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with reported biopsy proven acute rejection episodes		up to 6 months	No
Secondary	Incidence of adverse events		up to 6 months	No
Secondary	Incidence of Opportunistic Infections		Up to 5 years post transplant	No
Secondary	Patient and graft survival		up to 6 months	No
Secondary	Number of participants with malignancies		up to 6 months	No