C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection
NCT02936479 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2019-07-11
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.
Conditions
- Antibody Mediated Rejection of Kidney Transplant
Interventions
- DRUG
-
C1-INH (Berinert)
Sponsors & Collaborators
-
CSL Behring
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Robert Montgomery, MD · NYU Langone Health
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2018-10-30
- Completion
- 2018-10-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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