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Trial record 8 of 14 for:    mark stegall transplant

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01095887
Recruitment Status : Terminated (Poor enrollment)
First Posted : March 30, 2010
Results First Posted : June 19, 2015
Last Update Posted : July 20, 2015
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Mark Stegall, 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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Drug: Eculizumab Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Eculizumab

Arm Intervention/treatment
Experimental: eculizumab
Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
Drug: 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.
Other Name: Soliris

Primary Outcome Measures :
  1. Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant [ Time Frame: 3 months after kidney transplant surgery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01095887

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Alexion Pharmaceuticals
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Principal Investigator: Mark D Stegall Mayo Clinic
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Responsible Party: Mark Stegall, MD, Mayo Clinic Identifier: NCT01095887    
Other Study ID Numbers: 09-003392
UL1TR000135 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2010    Key Record Dates
Results First Posted: June 19, 2015
Last Update Posted: July 20, 2015
Last Verified: June 2015
Keywords provided by Mark Stegall, Mayo Clinic:
ABO incompatibility
living donor kidney transplant
kidney transplant
ABO blood type incompatible