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

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

Study Overview

• Status: Completed
• Conditions: Kidney Transplant Recipients
• Intervention / Treatment: Drug: ATF-Fresenius S

• Study Type: Observational
• Enrollment (Actual): 950

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Governmental Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ATF-Fresenius S; intravenous	Drug: ATF-Fresenius S; intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse event	up to 3 months post-transplantation

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma China, Inc.
• Investigators: Study Director: Medical Director, Astellas Pharma China, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2015
• Primary Completion (Actual): March 16, 2018
• Study Completion (Actual): March 16, 2018

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 13, 2015
• First Posted (Estimated): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: kidney transplant; ATG-F
• Other Study ID Numbers: ATG-MA-ACN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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/.