This trial is active, not recruiting.

Condition kidney transplant
Treatment eculizumab
Phase phase 1/phase 2
Target C5
Sponsor Mayo Clinic
Collaborator Alexion Pharmaceuticals
Start date March 2010
End date May 2014
Trial size 20 participants
Trial identifier NCT01095887, 09-003392


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Eculizumab will be given on Day 0, day 1, and weekly for the first four weeks after transplant.
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.

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Mayo Clinic.