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.

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000071022

Acronym

TAXI

Enrollment

240

Registered

2006-02-06

Start date

2001-05-13

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study was to compare the incidence of acute rejection in de novo renal transplant recipients with a high immunological risk who received either thymoglobulin or daclizumab induction.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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

Outcome results