Eculizumab Added to Conventional Treatment in the Prevention of Antibody-mediated Rejection in ABO Blood Group Incompatible Living Donor Kidney Transplantation



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:March 2010
End Date:June 2014
Contact:Nong Yowe Braaten, LPN
Phone:507-538-9617

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A Single Center, Open-label Study to Determine the Safety and Efficacy of a Dosing Regimen of Eculizumab Added to Conventional Treatment in the Prevention of Antibody-mediated Rejection (AMR) in ABO Blood Group Incompatible Living Donor Kidney Transplantation (ABOi LDKTx)

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.

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.

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)
We found this trial at
1
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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