Trials / Unknown
UnknownNCT03996278
Comparison Thymoglobulin® and Grafalon®
Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- University Hospital, Brest · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Grafalon | None interventional study but there are two groups |
Timeline
- Start date
- 2019-05-22
- Primary completion
- 2021-05-22
- Completion
- 2021-11-22
- First posted
- 2019-06-24
- Last updated
- 2020-07-07
Locations
13 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03996278. Inclusion in this directory is not an endorsement.