Skip to main content
OpenTrials
Completed

NCT Number: NCT02936479

C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection

This is an open-label, single arm trial in which patient who have ongoing antibody mediated rejection of a kidney transplant deemed refractory to maximal medical therapy are given the complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing antibody mediated injury. A maximum of 5 patients will be enrolled.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Antibody Mediated Rejection of Kidney Transplant

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Kidney transplant with acute antibody mediated rejection refractory to standard therapy

Exclusion criteria

  • Patients with known intolerance of or anaphylaxis to Berinert

Treatment and study plan

C1-INH (Berinert)

Drug

Primary outcomes

  1. Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR)

    Time frame: 24 months

    number of patients that presented with severe and refractory Antibody Mediated Renal (AMR) following kidney transplant and survived beyond one year after study drug administration

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • CSL Behring

Registry information

Official study title

Use of C1-INH (Berinert) for Renal Allograft Salvage in Refractory Antibody Mediated Rejection

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2016
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.