Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients
Safety and Efficacy of Individual Batches of ATG-F in Kidney Transplant Recipients: Multicentre, Prospective, Observational Study
1 other identifier
observational
950
1 country
25
Brief Summary
A multicenter, prospective, observational study to evaluate the safety and efficacy of individual batches of ATG-F in kidney transplant recipients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2015
CompletedFirst Submitted
Initial submission to the registry
March 13, 2015
CompletedFirst Posted
Study publicly available on registry
March 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2018
CompletedOctober 21, 2024
January 1, 2019
3.2 years
March 13, 2015
October 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of adverse event
up to 3 months post-transplantation
Secondary Outcomes (4)
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
Study Arms (1)
ATF-Fresenius S
intravenous
Interventions
Eligibility Criteria
Governmental Hospital
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
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
Ürümqi, China
Site: CN00001
Xi'an, China
Site: CN00033
Yantai, China
Site: CN00007
Zhengzhou, China
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma China, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2015
First Posted
March 18, 2015
Study Start
January 21, 2015
Primary Completion
March 16, 2018
Study Completion
March 16, 2018
Last Updated
October 21, 2024
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.