ALXN2023 - CONCORD (Antibody-Mediated Rejection after Kidney Transplant)

ALXN2023 - CONCORD (Antibody-Mediated Rejection after Kidney Transplant)

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Purpose of this Study

We are doing this study to find out if an experimental drug called ALXN2030 (the study drug) is a safe and effective option for people diagnosed with antibody-mediated rejection (AMR) of a transplanted kidney.

Who Can Participate?

Eligibility

Adults ages 18-75 who:
  • Are diagnosed with active or chronic active AMR
  • Are vaccinated against meningococcal infection, pneumonia, and influenza
For more information, contact the study team at hanajoy.porter@duke.edu.

Age Range

18-75

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment to either:
  • Get the study drug; OR
  • Get a placebo (inactive substance with no drug in it)
The study drug or placebo is given as an intravenous (IV) infusion every 3 months. Participation in the study will last for about 3 years.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN2030 in Adult Patients with Antibody-Mediated Rejection after Kidney Transplantation

Principal Investigator

Stuart
Knechtle

Protocol Number

PRO00117477

NCT ID

NCT06744647

Phase

II

Enrollment Status

Pending Open to Enrollment