A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
Completed
Conditions studied: Kidney Transplant Failure and Rejection
In brief
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 graft rejection episodes 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.
Key facts
- Study ID
- NCT03611621
- Run by
- Hansa Biopharma AB
- People needed
- 31
- Starts
- 2018-06-27
- Expected to finish
- 2023-02-14
- Last updated by the study team
- 2025-02-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Individuals deemed unable to comply with the protocol
- Inability by the judgment of the investigator to participate in the study for other reasons
Where it is running
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- The Johns Hopkins Hospital — Baltimore, Maryland, United States
- New York University School of Medicine — New York, New York, United States
- Necker Hospital — Paris, France
- Karolinska University Hospital — Stockholm, Sweden
- Uppsala University Hospital — Uppsala, Sweden
Full record on ClinicalTrials.gov
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