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Trial registered on ANZCTR


Registration number
ACTRN12611000880943
Ethics application status
Approved
Date submitted
11/08/2011
Date registered
17/08/2011
Date last updated
7/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety & Efficacy of Eculizumab to Prevent antibody mediated rejection in Living Donor Kidney Transplant Recipients Requiring Desensitization
Scientific title
A randomised, open-label, multicentre trial to determine safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in living donor kidney transplant recipients requiring desensitization therapy
Secondary ID [1] 262821 0
clinicaltrials.gov identifier NCT01399593
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney transplant 270544 0
Condition category
Condition code
Renal and Urogenital 270702 270702 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to standard of care or eculizumab.
Eculizumab will be administered by IV infusion over 45 minutes. There will be 9 doses of eculizumab over 9 weeks, with 1200mg intravenously just before transplant surgery, followed by 900mg dosed weekly for 4 weeks, then 1200mg administered fortnightly for 6 weeks.

Standard of Care: No Intervention. Patients will receive prophylactic therapy for AMR according to the hospital standard procedure post transplant.
Intervention code [1] 269170 0
Treatment: Drugs
Intervention code [2] 269199 0
Prevention
Comparator / control treatment
Eculizumab will be compared to standard of care using prophylactic treatments post transplantation.
Control group
Active

Outcomes
Primary outcome [1] 269417 0
The primary composite endpoint is the Week 9 post-transplantation treatment failure rate defined as the occurrence of 1) biopsy-proven AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up. The diagnosis of AMR will be based on kidney allograft
The primary analysis of all endpoints will occur after all patients have reached Month 12 post-transplantation.
Timepoint [1] 269417 0
Endpoints will be assessed at week 9 post transplant.
Secondary outcome [1] 287589 0
Cumulative incidence of AMR occurring between Week 9 and Month 12 post transplant.
Timepoint [1] 287589 0
Biopsies will be taken post reperfusion, at day 14, months 3 and 12. There will be another biopsy at month 36 post transplantation for long term follow up purposes.

Eligibility
Key inclusion criteria
1.Male or female patients >=18 years old
2.Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney transplant from a living donor to whom they are sensitized and require desensitization prior to transplantation
3.Able to understand the informed consent form and willing to comply with study procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
2.Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients who are desensitized and cleared for transplant by their doctor will be randomised 1:1 to either the treatment or SOC control arm. Randomisation will be performed centrally via internet.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised 1:1 utilising a web based randomisation system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3780 0
Canada
State/province [1] 3780 0
Country [2] 3781 0
France
State/province [2] 3781 0
Country [3] 3782 0
Germany
State/province [3] 3782 0
Country [4] 3783 0
Italy
State/province [4] 3783 0
Country [5] 3784 0
Norway
State/province [5] 3784 0
Country [6] 3785 0
Netherlands
State/province [6] 3785 0
Country [7] 3786 0
United States of America
State/province [7] 3786 0

Funding & Sponsors
Funding source category [1] 269645 0
Commercial sector/Industry
Name [1] 269645 0
Alexion Pharmaceuticals Australasia Pty Ltd
Country [1] 269645 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Alexion Pharmaceuticals Australasia Pty Ltd
Address
Suites 226-227, 117 Old Pittwater Road
Brookvale NSW 2100
Country
Australia
Secondary sponsor category [1] 266677 0
None
Name [1] 266677 0
Address [1] 266677 0
Country [1] 266677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269590 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 269590 0
Royal Adelaide Hosptial
North Terrace SA 5000
Ethics committee country [1] 269590 0
Australia
Date submitted for ethics approval [1] 269590 0
24/08/2011
Approval date [1] 269590 0
31/01/2012
Ethics approval number [1] 269590 0
RAH Protocol No 111130
Ethics committee name [2] 269591 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [2] 269591 0
Office for Research
Level 6 East, Main Building
300 Grattan Street
The Royal Melbourne Hospital
Parkville VIC 3050
Ethics committee country [2] 269591 0
Australia
Date submitted for ethics approval [2] 269591 0
23/09/2011
Approval date [2] 269591 0
Ethics approval number [2] 269591 0
Ethics committee name [3] 286759 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [3] 286759 0
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [3] 286759 0
Australia
Date submitted for ethics approval [3] 286759 0
13/02/2012
Approval date [3] 286759 0
Ethics approval number [3] 286759 0
Ethics committee name [4] 288761 0
Southern Health Human Research Ethics Committee
Ethics committee address [4] 288761 0
Ethics committee country [4] 288761 0
Australia
Date submitted for ethics approval [4] 288761 0
Approval date [4] 288761 0
Ethics approval number [4] 288761 0

Summary
Brief summary
Antibody mediated rejection post kidney transplant has become a significant clinical problem given that over 25% of kidney transplant candidates have antibodies to potential organ donors. There is no approved treatment for AMR and options to treat are limited. It is hoped that eculizumab will reduce the incidence of AMR post kidney transplantation in sensitized patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33007 0
Prof Graeme Russ
Address 33007 0
Renal Unit, Level 9 East Wing
Royal Adelaide Hosptial
North Terrace SA 5000
Country 33007 0
Australia
Phone 33007 0
618 8222 0932
Fax 33007 0
Email 33007 0
[email protected]
Contact person for public queries
Name 16254 0
Catherine Rowland
Address 16254 0
Alexion Pharmaceuticals Australasia Pty Ltd Suites 226-227, 117 Old Pittwater Road Brookvale NSW 2100
Country 16254 0
Australia
Phone 16254 0
+61 2 9091 0500
Fax 16254 0
+61 2 9091 0511
Email 16254 0
[email protected]
Contact person for scientific queries
Name 7182 0
Cheryl Townsend
Address 7182 0
Alexion Pharmaceuticals Australasia Pty Ltd Suites 226-227, 117 Old Pittwater Road Brookvale NSW 2100
Country 7182 0
Australia
Phone 7182 0
+61 2 9091 0500
Fax 7182 0
+61 2 9091 0511
Email 7182 0
[email protected]

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