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Terminated Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03221842

Public ClinicalTrials.gov record NCT03221842. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 2:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03221842
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
CSL Behring
Industry
Enrollment
63 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 6, 2017 (Actual)
Primary completion
Jan 20, 2021 (Actual)
Completion
Jan 20, 2021 (Actual)
Last update posted
Jul 29, 2022

2017 – 2021

United States locations

U.S. sites
13
U.S. states
12
U.S. cities
12
Facility City State ZIP Site status
University of Alabama Hospital (at Birmingham) Birmingham Alabama 35233 —
Mayo Clinic Arizona Phoenix Arizona 85054 —
California Pacific San Francisco California 94115 —
Yale New Haven Hospital New Haven Connecticut 06520 —
University of Illinois Chicago Chicago Illinois 60612 —
Brigham & Women's Boston Massachusetts 02115 —
Mayo Clinic (Rochester) Rochester Minnesota 55905 —
St. Barnabas Medical Center Livingston New Jersey 07039 —
NYU New York New York 10016 —
Columbia University New York New York 10032 —
Vanderbilt University Nashville Tennessee 37232 —
Houston Methodist Houston Texas 77030 —
University of Wisconsin Madison Wisconsin 53705-2281 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03221842, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 29, 2022 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03221842 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →