Eculizumab Added to Conventional Treatment in the Prevention of Antibody-mediated Rejection in ABO Blood Group Incompatible Living Donor Kidney Transplantation (ABOi)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Mark Stegall, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01095887
First received: March 26, 2010
Last updated: April 16, 2014
Last verified: April 2014

March 26, 2010
April 16, 2014
March 2010
May 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01095887 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Eculizumab Added to Conventional Treatment in the Prevention of 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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplant
Drug: eculizumab
You will receive eculizumab intravenously at the time of transplant, on the day after your transplant, then weekly for four weeks. At this time, your anti-blood group antibody levels will be determined. You may potentially receive eculizumab every two weeks for one year depending on these antibody levels.
Experimental: eculizumab
Eculizumab will be given on Day 0, day 1, and weekly for the first four weeks after transplant.
Intervention: Drug: eculizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
June 2014
May 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01095887
09-003392
Not Provided
Mark Stegall, Mayo Clinic
Mayo Clinic
Alexion Pharmaceuticals
Not Provided
Mayo Clinic
April 2014

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