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

NCT ID: NCT02936479

Last Updated: 2019-07-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-10-30

Brief Summary

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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

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Conditions

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Antibody Mediated Rejection of Kidney Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Berinert treatment

Group Type EXPERIMENTAL

C1-INH (Berinert)

Intervention Type DRUG

Interventions

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C1-INH (Berinert)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with known intolerance of or anaphylaxis to Berinert
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Montgomery, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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16-01851

Identifier Type: -

Identifier Source: org_study_id

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