Comparison Thymoglobulin® and Grafalon®
NCT03996278 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2020-07-07
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.
Conditions
- Renal Transplantation
Interventions
- OTHER
-
Grafalon
None interventional study but there are two groups
Sponsors & Collaborators
-
University Hospital, Brest
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-22
- Primary Completion
- 2021-05-22
- Completion
- 2021-11-22
Countries
- France
Study Locations
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