Comparison Thymoglobulin® and Grafalon® (THYGRET)

Regional University Hospital Center (CHRU)

Status: Unknown

Conditions: Renal Transplantation

Treatments: Other: Grafalon

Study type: Observational

Funder types: Other

Identifiers

NCT03996278

29BRC19.0018

Details and patient eligibility

About

This is a prospective, multicenter, observational, non -interventional study with comparison with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin (Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA occurrence and toxicities, various infections including CMV and BK virus incidence, MACE (major cardiac adverse event) and cancer.

Investigators will also compare cumulative treatment and follow up costs and other key criteria available in the ASTRE database.

Full description

This is a prospective, multicenter, observational, non -interventional study with comparison with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin (Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA occurrence and toxicities, various infections including CMV and BK virus incidence, MACE (major cardiac adverse event) and cancer.

Investigators will also compare cumulative treatment and follow up costs and other key criteria available in the ASTRE database.

Justification for a non-interventional study: in the study the medicinal products will be prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to the product is not decided in advance by a trial protocol but falls within current practice of the centre and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For the Grafalon prospective group: all first 11-12 patients from the 13 transplant centres receiving Grafalon according to the local practice
• For the Thymoglobulin group: a group of 130 patients matched for:

age (donor and recipient) gender indication (immunological indication versus DFG) CMV status

Exclusion criteria

• Patient younger than 18 years old
• Living donor
• Donor after cardiac death (because the Maastricht 3 donors are authorized recently in France)

Trial design

300 participants in 2 patient groups

Patients in the Grafalon group

Description:

Patients in the Grafalon group (n=150) will be followed prospectively and data prospectively collected thanks to the Astre database

Treatment:

Other: Grafalon

Patients in the Thymoglobulin group

Description:

Patients in the thymoglobulin group (n=150) will be selected and analyzed retrospectively from the Astre database

Treatment:

Other: Grafalon