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

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. Identifier: NCT01095887
Recruitment Status : Terminated (Poor enrollment)
First Posted : March 30, 2010
Results First Posted : June 19, 2015
Last Update Posted : July 20, 2015
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Mark Stegall, Mayo Clinic

March 26, 2010
March 30, 2010
June 3, 2015
June 19, 2015
July 20, 2015
May 2010
April 2014   (Final data collection date for primary outcome measure)
Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant [ Time Frame: 3 months after kidney transplant surgery ]
The primary outcome of this study is the incidence of acute humoral rejection (AHR) in the first 28 days after ABOi LDKTX. [ Time Frame: 28 days ]
Complete list of historical versions of study NCT01095887 on Archive Site
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Eculizumab to Prevent Antibody-mediated Rejection in ABO Blood Group Incompatible Living Donor Kidney Transplantation
A Single Center, Open-label Study to Determine the Safety and Efficacy of a Dosing Regimen of Eculizumab Added to Conventional Treatment in the Prevention of Antibody-mediated Rejection (AMR) in ABO Blood Group Incompatible Living Donor Kidney Transplantation (ABOi LDKTx)
The purpose of this study is to try to determine if the drug eculizumab can help prevent antibody-mediated rejection in patients undergoing a kidney transplant from a living donor with a different blood type than their own.
Kidney transplantation is considered the best therapy for patients with end-stage renal disease. In some instances, the only suitable living kidney donor is ABO blood group incompatible. This usually presents a barrier to successful transplantation because most recipients have circulating serum antibodies that bind to incompatible blood groups that will bind and damage the kidney allograft early after transplantation. Fortunately, over the past decade, we and others have developed protocols involving the pretransplant removal of anti-blood group antibodies using multiple plasmapheresis treatments that allow for the successful transplantation of ABOi LDKTx. Thus, this therapy enables patients to receive a living donor with its advantages rather than having to wait >5 years for a deceased donor kidney.
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Transplant
Drug: 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.
Other Name: Soliris
Experimental: eculizumab
Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
Intervention: Drug: Eculizumab
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be at least 18 years of age
  • Have end stage renal disease (ESRD) and is receiving a kidney transplant from a living donor to whom he/she has a baseline anti-blood group titer >1:32
  • Be vaccinated against N. meningitides (quadrivalent vaccine), H. Flu, and pneumococcal disease at least two weeks prior to beginning desensitization.

Exclusion Criteria:

  • Has an unstable cardiovascular condition
  • Has had a previous splenectomy
  • Has any active bacterial or other infection
  • Has a known or suspected hereditary complement deficiency
  • Has known hypersensitivity to the treatment drug or any of its excipients
  • Has history of illicit drug use or alcohol abuse within the previous year
  • Has history of meningococcal disease
  • Has any medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, pose an added risk for the patient, or confound the assessment of the patient (e.g. severe cardiovascular or pulmonary disease)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
UL1TR000135 ( U.S. NIH Grant/Contract )
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Mark Stegall, Mayo Clinic
Mayo Clinic
Alexion Pharmaceuticals
Principal Investigator: Mark D Stegall Mayo Clinic
Mayo Clinic
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP