Comparison Thymoglobulin® and Grafalon® (THYGRET)

July 6, 2020 updated by: University Hospital, Brest

Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients in the Grafalon group
Patients in the Grafalon group (n=150) will be followed prospectively and data prospectively collected thanks to the Astre database
Other: Grafalon
None interventional study but there are two groups
Other Names:
  • Thymoglobulin
Patients in the Thymoglobulin group
Patients in the thymoglobulin group (n=150) will be selected and analyzed retrospectively from the Astre database
Other: Grafalon
None interventional study but there are two groups
Other Names:
  • Thymoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison adverse events of the 2 ATGs and data collected thanks to the ASTRE database
Time Frame: During one year
All events: Death, graft loss, acute rejection, DGF, de novo DSA Severe infection (SAE), hematological adverse event (SAE), CMV infection, BK virus infection, MACE(major cardiac adverse event) and cancer
During one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recipient Efficacy (any adverse events)
Time Frame: During one year
comparison during the first year between the two groups for: patient and graft survival, delayed graft function, one year rate of acute rejection, occurrence od de novo DSA, renal function at one year (eGFR,MDRD)
During one year
Recipient Safety (any adverse events)
Time Frame: During one year
Comparison during the first year between the two groups for various infections (virus, bacteria, fungi), hematological adverse event (SAE or not)
During one year
Reconstitution of the T, and B cell populations
Time Frame: During one year
Reconstitution of the T, and B cell populations at D0, D7, M3, M12
During one year
Cost comparison
Time Frame: During one year
Hospitals costs at 1 year months (including re-hospitalisation costs)
During one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2019

Primary Completion (Anticipated)

May 22, 2021

Study Completion (Anticipated)

November 22, 2021

Study Registration Dates

First Submitted

May 28, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC19.0018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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