Clinical trial NCT02392312: Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients
Official title: Safety and Efficacy of Individual Batches of ATG-F in Kidney Transplant Recipients: Multicentre, Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Recipients
Keywords: kidney transplant
ATG-F
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Governmental Hospital

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of adverse event
timeFrame: up to 3 months post-transplantation
Secondary outcomes:
measure: Clinical diagnosis of acute rejection
timeFrame: up to 3 months post-transplantation
measure: Renal function: serum creatinine
timeFrame: at month 1 and month 3
measure: Incidence of delayed graft function (DGF)
timeFrame: up to 3 months post-transplantation
measure: Patient and graft survival
timeFrame: up to 3 months post-transplantation
Other outcomes:
Locations:
city: Baotou
country: China
facility: Site: CN00004
city: Beijing
country: China
facility: Site: CN00011
city: Beijing
country: China
facility: Site: CN00012
city: Beijing
country: China
facility: Site: CN00013
city: Changchun
country: China
facility: Site: CN00016
city: Chengdu
country: China
facility: Site: CN00002
city: Chongqing
country: China
facility: Site: CN00003
city: Fuzhou
country: China
facility: Site: CN00018
city: Guangzhou
country: China
facility: Site: CN00023
city: Haikou
country: China
facility: Site: CN00021
city: Haikou
country: China
facility: Site: CN00022
city: Hangzhou
country: China
facility: Site: CN00019
city: Hangzhou
country: China
facility: Site: CN00020
city: Jinan
country: China
facility: Site: CN00006
city: Jinan
country: China
facility: Site: CN00017
city: Kunming
country: China
facility: Site: CN00028
city: Nanchang
country: China
facility: Site: CN00030
city: Qingdao
country: China
facility: Site: CN00015
city: Shiyan
country: China
facility: Site: CN00010
city: Taiyuan
country: China
facility: Site: CN00014
city: Tianjin
country: China
facility: Site: CN00005
city: Wulumuqi
country: China
facility: Site: CN00031
city: Xi'an
country: China
facility: Site: CN00001
city: Yantai
country: China
facility: Site: CN00033
city: Zhengzhou
country: China
facility: Site: CN00007
Study officials:
affiliation: Astellas Pharma China, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: