Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000071022
Ethics application status
Approved
Date submitted
14/01/2010
Date registered
6/02/2006
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
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.
Secondary ID [1] 993 0
Cochrane Renal Group 020600038
Universal Trial Number (UTN)
Trial acronym
TAXI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incidence of acute rejection in renal transplantation 256527 0
Condition category
Condition code
Renal and Urogenital 256699 256699 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
daclizumab: 1 mg/kg (intravenous [IV] infusion) at days 0, 14, 28, 42 and 56 post transplant.
Intervention code [1] 255806 0
Treatment: Drugs
Comparator / control treatment
thymoglobulin: 1.25 mg/kg (once daily, IV infusion) from day 0 to 7 post transplant
Control group
Active

Outcomes
Primary outcome [1] 257587 0
Incidence of biopsy-proven acute allograft rejection
Timepoint [1] 257587 0
12 months post transplant
Secondary outcome [1] 262842 0
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.
Timepoint [1] 262842 0
12 months post transplant
Secondary outcome [2] 262843 0
Proportion of patients who experienced more than one episode of acute allograft rejection.
Timepoint [2] 262843 0
12 months post transplant
Secondary outcome [3] 262844 0
Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or anti-CD3 monoclonal antibodies).
Timepoint [3] 262844 0
12 months post transplant
Secondary outcome [4] 262845 0
Banff grade of the first rejection episode.
Timepoint [4] 262845 0
12 months post transplant
Secondary outcome [5] 262846 0
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
Timepoint [5] 262846 0
12 months post transplant
Secondary outcome [6] 262847 0
Incidence of delayed graft function defined as the need for hemodialysis within the first week post graft
Timepoint [6] 262847 0
12 months post transplant
Secondary outcome [7] 262848 0
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.
Timepoint [7] 262848 0
12 months post transplant
Secondary outcome [8] 262849 0
Graft survival (date of graft failure is the date when dialysis was restarted)
Timepoint [8] 262849 0
12 months post transplant
Secondary outcome [9] 262892 0
Patient survival (date of event is the date when the patient died)
Timepoint [9] 262892 0
12 months post transplant

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/05/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 2004 0
France
State/province [1] 2004 0

Funding & Sponsors
Funding source category [1] 256290 0
Hospital
Name [1] 256290 0
Regional Hospital of Lille
Country [1] 256290 0
France
Primary sponsor type
Hospital
Name
Centre Hospitalier Regional Universitaire (CHRU) de Lille
Address
Centre Hospitalier Regional Universitaire de Lille
rue Michel Polonowski
59000
Lille
Country
France
Secondary sponsor category [1] 251615 0
None
Name [1] 251615 0
Address [1] 251615 0
Country [1] 251615 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30142 0
Address 30142 0
Country 30142 0
Phone 30142 0
Fax 30142 0
Email 30142 0
Contact person for public queries
Name 13389 0
Prof, Christian, Noel
Address 13389 0
Head, Nephrology Department, Hopital Huriez - CHRU Lille, 59037 Lille Cedex
Country 13389 0
France
Phone 13389 0
+33 320 44 41 42
Fax 13389 0
Email 13389 0
[email protected]
Contact person for scientific queries
Name 4317 0
Prof, Marc, HAZZAN
Address 4317 0
Nephrology Department, Hopital Huriez - CHRU Lille, 59037 Lille Cedex
Country 4317 0
France
Phone 4317 0
+33 3 20 44 67 70
Fax 4317 0
+33 3 20 44 58 72
Email 4317 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.