Eculizumab to Prevent Antibody-mediated Rejection in ABO Blood Group Incompatible Living Donor Kidney Transplantation (ABOi)

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborator:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Mark Stegall, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01095887
First received: March 26, 2010
Last updated: June 3, 2015
Last verified: June 2015
Results First Received: June 3, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Transplant
Intervention: Drug: Eculizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled from May 2010 to September 2012 at the Mayo Clinic in Rochester, Minnesota.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Eculizumab

Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.

Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels.


Participant Flow:   Overall Study
    Eculizumab  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Eculizumab

Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.

Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels.


Baseline Measures
    Eculizumab  
Number of Participants  
[units: participants]
  6  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     2  
Gender  
[units: participants]
 
Female     3  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     6  



  Outcome Measures

1.  Primary:   Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant   [ Time Frame: 3 months after kidney transplant surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated early due to poor enrollment.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mark D. Stegall
Organization: Mayo Clinic
phone: 507-266-2812
e-mail: stegall.mark@mayo.edu


No publications provided


Responsible Party: Mark Stegall, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01095887     History of Changes
Other Study ID Numbers: 09-003392, UL1TR000135
Study First Received: March 26, 2010
Results First Received: June 3, 2015
Last Updated: June 3, 2015
Health Authority: United States: Institutional Review Board