Clinical trial NCT03996278: Comparison Thymoglobulin® and Grafalon®
Official title: Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Transplantation
Keywords: THYMOGLOBULINE®
GRAFALON®
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received or are receiving induction ATGs at the time of transplantation and whose data are collected from the ASTRE base in the 13 renal transplant centrers participating in the study.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Comparison adverse events of the 2 ATGs and data collected thanks to the ASTRE database
timeFrame: During one year
Secondary outcomes:
measure: Recipient Efficacy (any adverse events)
timeFrame: During one year
measure: Recipient Safety (any adverse events)
timeFrame: During one year
measure: Reconstitution of the T, and B cell populations
timeFrame: During one year
measure: Cost comparison
timeFrame: During one year
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie, Hopital Sud
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: CHRU de Brest
city: Caen
country: France
facility: CHU Hopital Clemenceau
city: Clermont-Ferrand
country: France
facility: CHU Hopital Gabriel Montpied
city: Limoges
country: France
facility: CHU Dupuytren 2
city: Paris
country: France
facility: Hopital Necker Enfant Malade
city: Poitiers
country: France
facility: CHU La Milétrie
city: Reims
country: France
facility: CHU Hopital Maison Blanche
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU Hopital de Bois Guillaume
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg - Hopital civil
city: Tours
country: France
facility: CHRU de Tours
Study officials:
References: