Comparison Thymoglobulin and Grafalon

  • STATUS
    Recruiting
  • End date
    Nov 22, 2021
  • participants needed
    300
  • sponsor
    University Hospital, Brest
Updated on 12 July 2020
Investigator
Yannick Lemeur, MD PhD
Primary Contact
CHU Dupuytren 2 (1.2 mi away) Contact
+13 other location
cancer
thymoglobulin
delayed graft function

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.

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.

Details
Treatment Grafalon
Clinical Study IdentifierNCT03996278
SponsorUniversity Hospital, Brest
Last Modified on12 July 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Kidney Transplantation or Organ Transplant or Renal transplant or Organ Transplantation or Organ Transplant - Pediatric?
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)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet