Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk

Renal Transplantation Clinical Trial

— TAXI  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682292
• Other study ID #: UHLillle
• Secondary ID: CRG020600038
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2008
• Last updated: May 21, 2008
• Start date: May 2001
• Est. completion date: November 2006

Study information

• Verified date: February 2004
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Third or fourth renal graft or

2. Current anti-HLA antibodies above or equal to 30% at the last evaluation or

3. Peak anti-HLA antibodies above or equal to 50% at the last evaluation or

4. A second graft if the first was lost within 2 years because of rejection.

5. Patients who gave their informed consent and are able to understand the scope of the study

Exclusion Criteria:

1. Transplantation from living donors or recipients of multiple grafts or patients who already have received another (non-renal) allograft.

2. Transplantation from a non-heart beating donor

3. Transplantation of two kidneys from the same donor

4. Patients with generalized infection at the time of transplantation

5. Women in child-bearing age who do not plan to use efficient contraception

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Erasme University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of biopsy-proven acute allograft rejection during the first post-transplant year		acute rejection proved by graft biopsy	No
Secondary	Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not at 1 year.		graft dysfunction	No
Secondary	Proportion of patients who experienced more than one episode of acute allograft rejection		graft dysfunction, biopsies	No
Secondary	Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or OKT3)		number of anti-lymphocyte treatment required for acute rejection episodes	No
Secondary	Number of acute rejection episodes per therapeutic arms and mean number of acute rejection episode per patient in each arm		graft dysfunction and biopsies	No
Secondary	Banff grade of the first rejection episode		graft biopsy	No
Secondary	Incidence of adverse events in the two treatment arms at 1 year		number of adverse events reported by the investigators	Yes
Secondary	Incidence of delayed graft function		number of patient who required hemodialysis during the first week post transplantation	Yes
Secondary	Graft function at 1 year		serum creatinine and estimated glomerular filtration rate	No
Secondary	Graft and patient survival at 1 year		number of graft failures and/or deaths	Yes