A multicenter open label study to compare efficacy and safety of induction treatment by ATG (thymoglobulin) versus anti-IL-2R (daclizumab) with a triple drug regimen (tacrolimus, mycophenolate mofetil, prednisone) in high risk renal transplant recipients.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12610000071022
• Date of registration: 06/02/2006
• Prospective Registration: No
• Primary sponsor: Centre Hospitalier Regional Universitaire (CHRU) de Lille
• Public title: A multicenter open label study to compare efficacy and safety of induction treatment by ATG (thymoglobulin) versus anti-IL-2R (daclizumab) with a triple drug regimen (tacrolimus, mycophenolate mofetil, prednisone) in high risk renal transplant recipients.
• Scientific title: A multicenter open label study to compare efficacy and safety of induction treatment by thymoglobulin (ATG) versus daclizumab (anti-IL-2R) with a triple drug regimen (tacrolimus, mycophenolate mofetil, prednisone) in high risk renal transplant recipients.
• Date of first enrolment: 13/05/2001
• Target sample size: 240
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12610000071022.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;

Countries of recruitment

France

Contacts

• Name: Prof, Christian, Noel

• Name: Prof, Marc, HAZZAN

Key inclusion & exclusion criteria

Inclusion criteria: Patients candidate for renal transplantation who fulfill the following criteria:

1) Third or fourth renal graft or

2) Current anti-Human Leukocyte Antigen (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

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Renal and Urogenital - Kidney disease

Incidence of acute rejection in renal transplantation;
Incidence of acute rejection in renal transplantation

Intervention(s)

daclizumab: 1 mg/kg (intravenous [IV] infusion) at days 0, 14, 28, 42 and 56 post transplant.

Primary Outcome(s)

Incidence of biopsy-proven acute allograft rejection[12 months post transplant]

Secondary Outcome(s)

Proportion of patients who experienced more than one episode of acute allograft rejection.[12 months post transplant]

Graft survival (date of graft failure is the date when dialysis was restarted)[12 months post transplant]

Incidence of delayed graft function defined as the need for hemodialysis within the first week post graft[12 months post transplant]

Patient survival (date of event is the date when the patient died)[12 months post transplant]

Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or anti-CD3 monoclonal antibodies).[12 months post transplant]

Graft function: serum creatinine and estimated glomerular filtration rate (GFR) calculated with the abbreviated Modification of the Diet in Renal Disease (aMDRD) and Cockcroft formulas.[12 months post transplant]

Incidence of adverse events in the two treatment arms at 1 year.
- leukopenia, anemia, thombopenia (weekly blood samples)
- infections: bacterial infections, cytomegalovirus, BK virus, pneumocystosis (blood or urine samples when clinical symptoms occurred)
- Post Transplant Lymphoproliferative Disorders[12 months post transplant]

Banff grade of the first rejection episode.[12 months post transplant]

Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not (serum creatinine increase, reversed after antirejection treatment) at 1 year.[12 months post transplant]

Secondary ID(s)

Cochrane Renal Group 020600038

Source(s) of Monetary Support

Regional Hospital of Lille