Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients
- Conditions
- Kidney Transplant Recipients
- Interventions
- Drug: ATF-Fresenius S
- Registration Number
- NCT02392312
- Lead Sponsor
- Astellas Pharma China, Inc.
- Brief Summary
A multicenter, prospective, observational study to evaluate the safety and efficacy of individual batches of ATG-F in kidney transplant recipients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 950
- 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.
- 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/Β΅l 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ATF-Fresenius S ATF-Fresenius S intravenous
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse event up to 3 months post-transplantation
- Secondary Outcome Measures
Name Time Method Clinical diagnosis of acute rejection up to 3 months post-transplantation Renal function: serum creatinine at month 1 and month 3 Incidence of delayed graft function (DGF) up to 3 months post-transplantation Patient and graft survival up to 3 months post-transplantation
Trial Locations
- Locations (25)
Site: CN00017
π¨π³Jinan, China
Site: CN00023
π¨π³Guangzhou, China
Site: CN00033
π¨π³Yantai, China
Site: CN00021
π¨π³Haikou, China
Site: CN00030
π¨π³Nanchang, China
Site: CN00014
π¨π³Taiyuan, China
Site: CN00005
π¨π³Tianjin, China
Site: CN00007
π¨π³Zhengzhou, China
Site: CN00012
π¨π³Beijing, China
Site: CN00013
π¨π³Beijing, China
Site: CN00002
π¨π³Chengdu, China
Site: CN00003
π¨π³Chongqing, China
Site: CN00022
π¨π³Haikou, China
Site: CN00020
π¨π³Hangzhou, China
Site: CN00018
π¨π³Fuzhou, China
Site: CN00028
π¨π³Kunming, China
Site: CN00015
π¨π³Qingdao, China
Site: CN00006
π¨π³Jinan, China
Site: CN00010
π¨π³Shiyan, China
Site: CN00001
π¨π³Xi'an, China
Site: CN00031
π¨π³Wulumuqi, China
Site: CN00004
π¨π³Baotou, China
Site: CN00011
π¨π³Beijing, China
Site: CN00016
π¨π³Changchun, China
Site: CN00019
π¨π³Hangzhou, China