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

Phase 2

Completed

• Conditions: Antibody Mediated Rejection of Kidney Transplant
• Interventions: Drug: C1-INH (Berinert)

• Registration Number: NCT02936479
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Results First Submitted: 2018-12-24
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-10
• Last Update Submitted: 2019-07-10
• Results First Posted: 2019-07-11
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

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

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Exclusion Criteria

• Patients with known intolerance of or anaphylaxis to Berinert

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Berinert treatment	C1-INH (Berinert)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States