Safety and Efficacy of Eculizumab to prevent antibody mediated rejection in sensitized kidney transplant recipients from a deceased donor

An open-label, single-arm, multicentre trial to determine safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in sensitized recipients of a kidney transplant from a deceased donor.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000333819

Enrollment

Registered

2012-03-22

Start date

2012-11-02

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Antibody mediated rejection post kidney transplant has become a significant clinical problem given that over 25% of kidney transplant candidates have antibodies (are sensitized) to potential organ donors. Currently there are no approved treatments for AMR and options to treat are limited. It is hoped that eculizumab will reduce the incidence of AMR post kidney transplant from deceased donors to whom the recipient is sensitized.

Interventions

Patients will receive eculizumab by IV infusion over 45 minutes. All patients will receive study drug for 9 weeks post transplantation. There will be 9 doses of eculizumab over 9 weeks, with 1200mg intravenously just before transplant reperfusion, followed by 900mg dosed weekly for 4 weeks, then 1200mg administered fortnightly for 6 weeks.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with stage V chronic kidney disease who will receive a kidney transplant from a deceased donor to whom they are sensitized; able to understand the informed consent form and willing to complly with study procedures.

Exclusion criteria

Prior treatment with eculizumab; blood type incompatible with donor; any medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confounds the assessment of the patient.

Outcome results