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

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Alexion Pharmaceuticals
• Treatments: Antibodies; Eculizumab; Immunoglobulins

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)