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Completed

NCT Number: NCT02392312

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

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

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Key information

Conditions

Kidney Transplant Recipients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site: CN00004, Baotou, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATF-Fresenius S

Drug

intravenous

Primary outcomes

  1. Incidence and severity of adverse event

    Time frame: up to 3 months post-transplantation

Secondary outcomes

  1. Clinical diagnosis of acute rejection

    Time frame: up to 3 months post-transplantation

  2. Renal function: serum creatinine

    Time frame: at month 1 and month 3

  3. Incidence of delayed graft function (DGF)

    Time frame: up to 3 months post-transplantation

  4. Patient and graft survival

    Time frame: up to 3 months post-transplantation

Sponsors and collaborators

Lead sponsor

Astellas Pharma China, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2015
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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