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

NYU Langone Health

Status and phase: Completed; Phase 2

Conditions: Antibody Mediated Rejection of Kidney Transplant

Treatments: Drug: C1-INH (Berinert)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02936479

16-01851

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients with known intolerance of or anaphylaxis to Berinert

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Berinert treatment

Experimental group

Treatment:

Drug: C1-INH (Berinert)