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

Phase 1

Terminated

• Conditions: Kidney Transplant
• Interventions: Drug: Eculizumab

• Registration Number: NCT01095887
• Lead Sponsor: Mayo Clinic

Brief 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.

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.

Study Timeline

• Study First Submitted: 2010-03-26
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Study Start: 2010-05
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-06
• Results First Submitted: 2015-06-03
• Results First Submitted QC: 2015-06-03
• Results First Posted: 2015-06-19
• Last Update Submitted: 2015-06-26
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
eculizumab	Eculizumab	Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant	3 months after kidney transplant surgery

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States