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Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients

A Double-blind, Randomized-withdrawal, Placebo-controlled Study to Evaluate the Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection in Adult Renal Transplant Recipients

NCT03221842•CSL Behring

View on ClinicalTrials.gov

Summary

This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female at least 18 years of age;
•Evidence of at least one donor-specific antibody (DSA);
•Recipient of a kidney transplant;
•Achieved a steady-state, post-transplant eGFR ≥ 40 mL/min/1.73 m2 within 60 days of post-transplant OR a 50% increase in urine output with a 50% decrease in serum creatinine over the first 7 days post-transplant in subjects with slow or delayed graft function;
•Acute AMR.

Exclusion Criteria

•Recipient of an en bloc kidney transplant;
•Current active hepatitis C virus (HCV) infection;
•Active bacterial or fungal infection;
•Ongoing dialysis \>2 weeks;
•Known congenital bleeding or coagulopathy disorder;
•Current cancer or a history of cancer;
•Female subjects who are pregnant or breast feeding;
•Male or female subjects who are unwilling to use contraception or who are not surgically sterile.

Locations (26)

University of Alabama Hospital (at Birmingham)

Birmingham, Alabama, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

California Pacific

San Francisco, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

University of Illinois Chicago

Chicago, Illinois, United States

Brigham & Women's

Boston, Massachusetts, United States

Mayo Clinic (Rochester)

Rochester, Minnesota, United States

St. Barnabas Medical Center

Livingston, New Jersey, United States

NYU

New York, New York, United States

Columbia University

New York, New York, United States

Key Dates

Start Date

November 6, 2017

Primary Completion Date

January 20, 2021

Completion Date

January 20, 2021

Last Updated

July 29, 2022

Enrollment

ACTUAL participants

Conditions

Antibody-mediated Rejection

Interventions

C1-esterase inhibitor

DRUG

Placebo

DRUG

Biorepository and Registry for Plasma Exchange Patients

NCT05004493

Antibody-mediated RejectionNMO Spectrum Disorder+2 more

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RECRUITINGPHASE3

TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

NCT04561986

Antibody-mediated Rejection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients

Inclusion Criteria

Exclusion Criteria

Biorepository and Registry for Plasma Exchange Patients

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