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

Mayo Clinic

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Kidney Transplant

Treatments

Drug: Eculizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01095887

09-003392

UL1TR000135 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)