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

NCT ID: NCT01095887

Last Updated: 2015-07-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2014-04-30

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.

Conditions

Kidney Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

eculizumab

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

Group Type: EXPERIMENTAL

Eculizumab

Intervention Type: DRUG

Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels.

Interventions

Eculizumab

Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels.

Intervention Type: DRUG

Other Intervention Names

Soliris

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mark Stegall

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark D Stegall

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

UL1TR000135

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-003392

Identifier Type: -

Identifier Source: org_study_id