Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients

Astellas

Status: Completed

Conditions: Kidney Transplant Recipients

Treatments: Drug: ATF-Fresenius S

Study type: Observational

Funder types: Industry

Identifiers

NCT02392312

ATG-MA-ACN001

Details and patient eligibility

About

A multicenter, prospective, observational study to evaluate the safety and efficacy of individual batches of ATG-F in kidney transplant recipients.

Enrollment: 950 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ATG-F administration to prophylaxis rejection in kidney transplantation recipient.
• Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.

Exclusion criteria

• Hypersensitivity to the active substance or to any of the excipients.).
• Subjects with bacterial, viral, mycotic or parasitic infections, which are not under adequate therapeutic control.
• Solid organ transplant subjects with severe thrombocytopenia, i.e. less than 50,000 platelets/µl because ATG-F may enhance thrombocytopenia and thus increase the risk of hemorrhage.
• Current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully.
• Subject is receiving a Human Leukocyte Antibody (HLA) identical living donor organ.
• Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance.

Trial design

950 participants in 1 patient group

ATF-Fresenius S

Description:

intravenous

Treatment:

Drug: ATF-Fresenius S