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

NYU Langone Health1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Antibody Mediated Rejection of Kidney Transplant

Interventions

C1-INH (Berinert)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Kidney transplant with acute antibody mediated rejection refractory to standard therapy Exclusion Criteria: * Patients with known intolerance of or anaphylaxis to Berinert

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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

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

Time frame: 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.