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

This study has been terminated.
(Poor enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01095887
First Posted: March 30, 2010
Last Update Posted: July 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Mark Stegall, Mayo Clinic
Results First Submitted: June 3, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Kidney Transplant
Intervention: Drug: Eculizumab

  Participant Flow
  Hide Participant Flow

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 
Overall Participants Analyzed 
[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



Responsible Party: Mark Stegall, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01095887     History of Changes
Other Study ID Numbers: 09-003392
UL1TR000135 ( U.S. NIH Grant/Contract )
First Submitted: March 26, 2010
First Posted: March 30, 2010
Results First Submitted: June 3, 2015
Results First Posted: June 19, 2015
Last Update Posted: July 20, 2015