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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 (ABOi)

This study is currently recruiting participants.
Verified October 2012 by Mayo Clinic
Sponsor:
Collaborator:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Mark Stegall, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01095887
First received: March 26, 2010
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Transplant
 Drug: eculizumab
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Drug Information available for: Eculizumab
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eculizumab
Eculizumab will be given on Day 0, day 1, and weekly for the first four weeks after 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095887

Contacts
Contact: Nong Yowe Braaten, LPN 507-538-9617

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nong Yowe Braaten, LPN     507-538-9617        
Principal Investigator: Mark D. Stegall, MD            
Sponsors and Collaborators
Mayo Clinic
Alexion Pharmaceuticals
  More Information

No publications provided

Responsible Party: Mark Stegall, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01095887     History of Changes
Other Study ID Numbers: 09-003392
Study First Received: March 26, 2010
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
ABO incompatibility
living donor kidney transplant
kidney transplant
ABO blood type incompatible
Living donor kidney transplant

Additional relevant MeSH terms:
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013