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

Kidney Transplant Recipients Clinical Trial

Official title:

Safety and Efficacy of Individual Batches of ATG-F in Kidney Transplant Recipients: Multicentre, Prospective, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392312
• Other study ID #: ATG-MA-ACN001
• Status: Completed
• Start date: January 21, 2015
• Est. completion date: March 16, 2018

Study information

• Verified date: January 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 950
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Recipients

Intervention

Drug:
• ATF-Fresenius S
intravenous

Locations

Country	Name	City	State
China	Site: CN00004	Baotou
China	Site: CN00011	Beijing
China	Site: CN00012	Beijing
China	Site: CN00013	Beijing
China	Site: CN00016	Changchun
China	Site: CN00002	Chengdu
China	Site: CN00003	Chongqing
China	Site: CN00018	Fuzhou
China	Site: CN00023	Guangzhou
China	Site: CN00021	Haikou
China	Site: CN00022	Haikou
China	Site: CN00019	Hangzhou
China	Site: CN00020	Hangzhou
China	Site: CN00006	Jinan
China	Site: CN00017	Jinan
China	Site: CN00028	Kunming
China	Site: CN00030	Nanchang
China	Site: CN00015	Qingdao
China	Site: CN00010	Shiyan
China	Site: CN00014	Taiyuan
China	Site: CN00005	Tianjin
China	Site: CN00031	Wulumuqi
China	Site: CN00001	Xi'an
China	Site: CN00033	Yantai
China	Site: CN00007	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse event		up to 3 months post-transplantation
Secondary	Clinical diagnosis of acute rejection		up to 3 months post-transplantation
Secondary	Renal function: serum creatinine		at month 1 and month 3
Secondary	Incidence of delayed graft function (DGF)		up to 3 months post-transplantation
Secondary	Patient and graft survival		up to 3 months post-transplantation