A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:8/5/2018
Start Date:June 27, 2018
End Date:December 1, 2022
Contact:Gunilla Eckerwall, PhD
Email:gunilla.eckerwall@hansamedical.com
Phone:+46 733420405

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A Prospective Observational, Long Term Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation

The rationale for the current protocol is to collect data from extended follow up in subjects
that have received a kidney transplant following imlifidase dosing to provide a better
understanding regarding the long-term outcome for these subjects. Data of parameters such as
patient and graft survival, comorbidity, treatment of rebound of DSAs and quality of life as
well as anti-drug antibody levels will be collected.

This prospective, observational follow up study of subjects who have received imlifidase
prior to kidney transplantation will provide important data to future prescribers and
patients of the potential long-term benefits of imlifidase mediated transplantation.


Inclusion Criteria:

- Signed Informed Consent obtained before any study-related procedures

- Previous dosing with imlifidase followed by kidney transplantation and participation
in one of the following clinical studies: 13-HMedIdeS-02, 13-HMedIdeS-03,
14-HMedIdeS-04 or 15-HMedIdeS-06

Exclusion Criteria:

- Individuals deemed unable to comply with the protocol

- Inability by the judgment of the investigator to participate in the study for other
reasons
We found this trial at
4
sites
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Niraj Desai, MD
Phone: 410-614-8297
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Stanley Jordan, MD
Phone: 310-423-8282
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Robert A Montgomery
Phone: 646-501-2418
New York University School of Medicine NYU School of Medicine has a proud history that...
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149 Rue de Sèvres
Paris, 75743
Principal Investigator: Christophe Legendre, MD
Phone: +33 1 44 49 53 55
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