Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Crossmatch Deceased Donor Kidney Transplant

• Status: Terminated
• Trial end date: 2016-08-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test whether a dosing regimen of eculizumab in addition to standard posttransplant care in positive crossmatch deceased donor kidney transplant recipients will reduce the incidence of acute humoral rejection (AHR).

Patients included in this study will be those who have demonstrable anti-human leukocyte antigen (HLA) antibody specific for their deceased donor. It is our hypothesis that blockade of terminal complement activation with eculizumab at the time of transplant in combination with our current protocols will reduce the incidence of AHR in recipients of deceased donor kidney transplants who have anti-donor HLA antibody

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Alexion Pharmaceuticals
• Treatments: Eculizumab

Criteria

Inclusion Criteria:

• 18 years of age

• Has end stage renal disease (ESRD) and is to receive a kidney transplant from a deceased donor (DD) to whom he/she has a positive T or B cell crossmatch >200 at the time of transplant and DSA demonstrated by solid phase assays.

• Willing to comply with the protocol

• Females of child-bearing potential must have a negative pregnancy test (serum β-HCG) and sexually active females must agree to use a reliable and medically approved method of contraception

• Willing and able to give written informed consent

• Vaccinated against Neisseria meningitides (quadrivalent vaccine), Pneumococcus and H. influenzae at least two weeks prior to beginning desensitization

Exclusion Criteria:

• Unstable cardiovascular condition

• Previous splenectomy

• Active bacterial or other infection which is clinically significant in the opinion of the investigator

• Known or suspected hereditary complement deficiency

• Participation in any other investigational drug study or was exposed to an investigational drug or device within 30 days of randomization

• Pregnant, breast-feeding, or intending to conceive during the course of the study, including a one month follow-up period after drug discontinuation

• Known hypersensitivity to the treatment drug or any of its excipients

• History of illicit drug use or alcohol abuse within the previous year

• History of meningococcal disease

• 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)