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

NCT01095887 | Terminated Phase 1 Results

• 2 other identifiers: 09-003392UL1TR000135
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant

Keywords

ABO incompatibility; living donor kidney transplant; kidney transplant; ABO blood type incompatible

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Antibody-Mediated Rejection (AMR) Within 3 Months of Kidney Transplant

  3 months after kidney transplant surgery

Study Arms (1)

eculizumab

EXPERIMENTAL

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

Drug: Eculizumab

Interventions

Eculizumab 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.

Also known as: Soliris

eculizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• Alexion Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

eculizumab

Limitations and Caveats

The study was terminated early due to poor enrollment.

Results Point of Contact

• Title: Dr. Mark D. Stegall
• Organization: Mayo Clinic

stegall.mark@mayo.edu

507-266-2812

Study Officials

• Mark D Stegall

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: March 30, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 20, 2015
• Results First Posted: June 19, 2015

Record last verified: 2015-06

Locations

US (1)