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

Completed

• 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

Study Timeline

• Study Start: 2015-01-21
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-13
• Study First Posted: 2015-03-18
• Primary Completion: 2018-03-16
• Study Completion: 2018-03-16
• Status Verified: 2019-01
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 950

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.

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; 🇨🇳 Jinan, China

Site: CN00023; 🇨🇳 Guangzhou, China

Site: CN00033; 🇨🇳 Yantai, China

Site: CN00021; 🇨🇳 Haikou, China

Site: CN00030; 🇨🇳 Nanchang, China

Site: CN00014; 🇨🇳 Taiyuan, China

Site: CN00005; 🇨🇳 Tianjin, China

Site: CN00007; 🇨🇳 Zhengzhou, China

Site: CN00012; 🇨🇳 Beijing, China

Site: CN00013; 🇨🇳 Beijing, China

Site: CN00002; 🇨🇳 Chengdu, China

Site: CN00003; 🇨🇳 Chongqing, China

Site: CN00022; 🇨🇳 Haikou, China

Site: CN00020; 🇨🇳 Hangzhou, China

Site: CN00018; 🇨🇳 Fuzhou, China

Site: CN00028; 🇨🇳 Kunming, China

Site: CN00015; 🇨🇳 Qingdao, China

Site: CN00006; 🇨🇳 Jinan, China

Site: CN00010; 🇨🇳 Shiyan, China

Site: CN00001; 🇨🇳 Xi'an, China

Site: CN00031; 🇨🇳 Wulumuqi, China

Site: CN00004; 🇨🇳 Baotou, China

Site: CN00011; 🇨🇳 Beijing, China

Site: CN00016; 🇨🇳 Changchun, China

Site: CN00019; 🇨🇳 Hangzhou, China