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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01567085




Registration number
NCT01567085
Ethics application status
Date submitted
27/03/2012
Date registered
30/03/2012
Date last updated
3/05/2019

Titles & IDs
Public title
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
Scientific title
An Open-Label, Single-Arm, Multicenter 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] 0 0
2010-019631-35
Secondary ID [2] 0 0
C10-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage V Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Eculizumab - Eculizumab 1200 milligrams (mg) was administered intravenously (IV) over 25 to 45 minutes 1 hour prior to kidney allograft reperfusion.

Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days.

Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation
Timepoint [1] 0 0
Baseline, Week 9

Eligibility
Key inclusion criteria
1. Male or female participants =18 years old.
2. Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized.
3. History of prior exposure to HLA (human leukocyte antigen):

* Prior solid organ or tissue allograft
* Pregnancy
* Blood transfusion
* Prior exposure to specific donor's HLA
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has received treatment with eculizumab at any time prior to enrolling in this study.
2. Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor.
3. History of severe cardiac disease.
4. Prior splenectomy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/05/2017
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Bordeaux
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
France
State/province [3] 0 0
Toulouse
Country [4] 0 0
France
State/province [4] 0 0
Tours
Country [5] 0 0
Italy
State/province [5] 0 0
Brescia
Country [6] 0 0
Italy
State/province [6] 0 0
Padova
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona
Country [8] 0 0
Sweden
State/province [8] 0 0
Gothenburg
Country [9] 0 0
Sweden
State/province [9] 0 0
Uppsala
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Cambridge
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
Trial website
https://clinicaltrials.gov/study/NCT01567085
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01567085