Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01399593




Trial ID
NCT01399593
Ethics application status
Date submitted
19/07/2011
Date registered
20/07/2011
Date last updated
4/09/2017

Titles & IDs
Public title
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
Scientific title
A Randomized, Open-label, Multicenter 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] 0 0
2010-019630-28
Secondary ID [2] 0 0
C10-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antibody Mediated Rejection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eculizumab

Experimental: Eculizumab - Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously: the median infusion time was 39 minutes.

No Intervention: Standard of Care - Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.


Treatment: Drugs: Eculizumab


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment Failure Rate - The primary efficacy variable was a binary outcome variable where patients meeting the composite endpoint of the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up definition at Week 9 post-transplantation were considered treatment failures and all others were considered treatment successes.
Timepoint [1] 0 0
9 weeks post-transplantation

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. ABO incompatible with living donor

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
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
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
- North Terrace
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Clayton VIC
Recruitment hospital [4] 0 0
- Parkville VIC
Recruitment postcode(s) [1] 0 0
5000 - North Terrace
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
3168 - Clayton VIC
Recruitment postcode(s) [4] 0 0
3050 - Parkville VIC
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
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United States of America
State/province [6] 0 0
Maryland
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United States of America
State/province [7] 0 0
Massachusetts
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United States of America
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Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Texas
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Toulouse Cedex
Country [18] 0 0
France
State/province [18] 0 0
Tours Cedex
Country [19] 0 0
Germany
State/province [19] 0 0
Dresden
Country [20] 0 0
Germany
State/province [20] 0 0
Heidelberg
Country [21] 0 0
Italy
State/province [21] 0 0
Milan
Country [22] 0 0
Italy
State/province [22] 0 0
Padova
Country [23] 0 0
Netherlands
State/province [23] 0 0
Rotterdam
Country [24] 0 0
Norway
State/province [24] 0 0
Oslo
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
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Sweden
State/province [26] 0 0
Göteborg
Country [27] 0 0
Sweden
State/province [27] 0 0
Huddinge
Country [28] 0 0
Sweden
State/province [28] 0 0
Uppsala
Country [29] 0 0
United Kingdom
State/province [29] 0 0
England
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Birmingham
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United Kingdom
State/province [31] 0 0
Cambridge
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United Kingdom
State/province [32] 0 0
Coventry

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alexion Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this trial was to determine the safety and efficacy of eculizumab in the
prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor
kidney transplant requiring desensitization therapy.
Trial website
https://clinicaltrials.gov/show/NCT01399593
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Masayo Ogawa, MD
Address 0 0
Alexion Pharmaceuticals
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