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 | 
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.
			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
	
			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
	
			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
	
			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
	
			
					Paris, 75743
Principal Investigator: Christophe Legendre, MD
			
						
										Phone: +33 1 44 49 53 55
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