Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000333819
Ethics application status
Approved
Date submitted
21/03/2012
Date registered
22/03/2012
Date last updated
7/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Efficacy of Eculizumab to prevent antibody mediated rejection in sensitized kidney transplant recipients from a deceased donor
Scientific title
An open-label, single-arm, multicentre trial to determine safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in sensitized recipients of a kidney transplant from a deceased donor.
Secondary ID [1] 280197 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
kidney transplant 285918 0
Condition category
Condition code
Renal and Urogenital 286109 286109 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive eculizumab by IV infusion over 45 minutes. All patients will receive study drug for 9 weeks post transplantation. There will be 9 doses of eculizumab over 9 weeks, with 1200mg intravenously just before transplant reperfusion, followed by 900mg dosed weekly for 4 weeks, then 1200mg administered fortnightly for 6 weeks.
Intervention code [1] 284332 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286584 0
The primary composite endpoint is the week 9 post transplantation treatment failure rate defined as the occurrence of biopsy-proven AMR, graft loss, patient death or loss to follow up.
Timepoint [1] 286584 0
Endpoints will be assessed at week 9 post transplant.
Primary outcome [2] 286797 0
Safety and efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplant will also be evaluated. Evaluation of these endpoints will be assessed by monitoring of all adverse events (including serious adverse events, regular monitoring of blood test results), incidence of clinically significant infection requiring intervention, incidence of biopsy-proven acute cellular rejection and incidence of allograft loss for reasons other than AMR.
Commonly reported AEs on this drug include headache, thrombocytopenia, viral infection and more severe infection including sepsis.
Timepoint [2] 286797 0
Endpoints will be evaluated at week 9 and month 12 post transplantation.
Secondary outcome [1] 296218 0
Cumulative incidence of AMR occurring between week 9 and month 12 post transplant.
Timepoint [1] 296218 0
Biopsies will be taken post reperfusion, day 14, month 3, month 12 and month 36 post transplant

Eligibility
Key inclusion criteria
Patients with stage V chronic kidney disease who will receive a kidney transplant from a deceased donor to whom they are sensitized; able to understand the informed consent form and willing to complly with study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior treatment with eculizumab; blood type incompatible with donor; 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients who are candidates for deceased donor kidney transplantation and who are sensitized to their deceased donor and meet entry criteria will be considered for this study. Patients will be screened and enrolled within 24 hours prior to transplantation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is an open label, single arm study so all eligible patients will receive study drug.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
15/06/2012
Actual
2/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 548 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 549 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 550 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 5085 0
2050
Recruitment postcode(s) [2] 6289 0
5000 - Adelaide
Recruitment postcode(s) [3] 6290 0
3168 - Clayton
Recruitment outside Australia
Country [1] 4165 0
France
State/province [1] 4165 0
Country [2] 4166 0
Italy
State/province [2] 4166 0
Country [3] 4167 0
Spain
State/province [3] 4167 0
Country [4] 4168 0
United Kingdom
State/province [4] 4168 0

Funding & Sponsors
Funding source category [1] 284766 0
Commercial sector/Industry
Name [1] 284766 0
Alexion Pharmaceuticals Inc
Country [1] 284766 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Alexion Pharmaceuticals Inc
Address
Alexion Pharmaceuticals Australasia Pty Ltd
Suites 226-227, 117 Old Pittwater Road
Brookvale NSW 2100
Country
Australia
Secondary sponsor category [1] 283657 0
None
Name [1] 283657 0
Address [1] 283657 0
Country [1] 283657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286760 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 286760 0
Royal Adelaide Hospital
North Terrace SA 5000
Ethics committee country [1] 286760 0
Australia
Date submitted for ethics approval [1] 286760 0
22/02/2012
Approval date [1] 286760 0
11/06/2012
Ethics approval number [1] 286760 0
Ethics committee name [2] 286793 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [2] 286793 0
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [2] 286793 0
Australia
Date submitted for ethics approval [2] 286793 0
12/03/2012
Approval date [2] 286793 0
11/04/2012
Ethics approval number [2] 286793 0
Ethics committee name [3] 288759 0
Southern Health Human Research Ethics Committee
Ethics committee address [3] 288759 0
Ethics committee country [3] 288759 0
Australia
Date submitted for ethics approval [3] 288759 0
Approval date [3] 288759 0
06/12/2012
Ethics approval number [3] 288759 0
Ethics committee name [4] 288760 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [4] 288760 0
Office for Research
6 East, Central Building
The Royal Melbourne Hospital
300 Grattan Street
PARKVILLE VIC 3050
Ethics committee country [4] 288760 0
Australia
Date submitted for ethics approval [4] 288760 0
Approval date [4] 288760 0
Ethics approval number [4] 288760 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 (are sensitized) to potential organ donors. Currently there are no approved treatments for AMR and options to treat are limited. It is hoped that eculizumab will reduce the incidence of AMR post kidney transplant from deceased donors to whom the recipient is sensitized.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33823 0
Prof Steve Chadban
Address 33823 0
Renal Unit, Royal Prince Alfred Hospital
Level 9, Main Building,
Missenden Road, Camperdown NSw 2050
Country 33823 0
Australia
Phone 33823 0
612 9515 6329
Fax 33823 0
Email 33823 0
[email protected]
Contact person for public queries
Name 17070 0
Ms Catherine Rowland
Address 17070 0
Alexion Pharmaceuticals Australasia Pty Ltd Suites 226-227, 117 Old Pittwater Road Brookvale NSW 2100
Country 17070 0
Australia
Phone 17070 0
+ 61 2 9091 0500
Fax 17070 0
+ 61 2 9091 0511
Email 17070 0
[email protected]
Contact person for scientific queries
Name 7998 0
Ms Cheryl Townsend
Address 7998 0
Alexion Pharmaceuticals Australasia Pty Ltd Suites 226-227, 117 Old Pittwater Road Brookvale NSW 2100
Country 7998 0
Australia
Phone 7998 0
+ 61 2 9091 0500
Fax 7998 0
+ 61 2 9091 0511
Email 7998 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

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