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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02392312

Enrollment

950

Registered

2015-03-18

Start date

2015-01-21

Completion date

2018-03-16

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Recipients

Keywords

kidney transplant, ATG-F

Brief summary

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

Interventions

DRUGATF-Fresenius S

intravenous

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026