NCT00682292

Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk

Multicenter Randomized Study to Compare Induction Therapy With Polyclonal Antithymocytes Globulins (ATG) Versus Monoclonal Anti-IL2R Antibody (Daclizumab) in a Triple Drug Regimen in Renal Transplant Recipients With High Immunological Risk.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.

Detailed description

The objective of this randomized, multi-center trial is to directly compare the ATG, Thymoglobulin, with the anti-CD25 mAb, daclizumab, in a high-risk, HLA-sensitized renal transplant population, in order to elucidate whether there is any significant difference in the incidence of acute rejection after one year. Eligible patients were randomized (1:1) to receive either ATG (1.25 mg/kg/d from day 0 to day 7) or daclizumab (1 mg/kg at days 0, 14, 28, 42 and 56). Maintenance immunosuppression comprised tacrolimus, MMF and prednisone. The study's primary endpoint was the incidence of biopsy-proven acute rejection at one year.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Thymoglobulin (ATG)	Thymoglobulin: 1.25 mg/kg per day from day 0 to day 7 post transplantation
DRUG	Daclizumab	Daclizumab: 1mg/kg at day 0, 14, 28, 42 and 56 post transplantation

Timeline

• Start date: 2001-05-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2008-05-22
• Last updated: 2008-05-22

Locations

1 site across 1 country: France