Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT01567085
Ethics application status
Date submitted
27/03/2012
Date registered
28/03/2012
Date last updated
12/09/2017

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
Treatment: Drugs - Eculizumab

Experimental: Eculizumab -


Treatment: Drugs: Eculizumab
Eculizumab 1200 mg (4 vials) administered intravenously (IV) over 35 to 45 minutes.
Eculizumab 900 mg (3 vials) administered IV over 35 to 45 minutes.

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

Outcomes
Primary outcome [1] 0 0
Post-transplantation treatment failure rate
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
1. Male or female patients = 18 years old

2. Patients with Stage V chronic kidney disease who will receive a kidney transplant from
a deceased donor to whom they are 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
Gender
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. ABO (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
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
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
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)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- North Terrace
Recruitment hospital [3] 0 0
- Parkville VIC
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5000 - North Terrace
Recruitment postcode(s) [3] 0 0
3050 - Parkville VIC
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
Upsala
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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

To evaluate the safety and potential efficacy of eculizumab to prevent Antibody Mediated
Rejection (AMR) in sensitized recipients of deceased donor kidney transplants.
Trial website
https://clinicaltrials.gov/show/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