NCT03996278

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
Last Updated

July 7, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

May 28, 2019

Last Update Submit

July 6, 2020

Conditions

Renal Transplantation

Keywords

THYMOGLOBULINE®GRAFALON®

Outcome Measures

Primary Outcomes (1)

  • Comparison adverse events of the 2 ATGs and data collected thanks to the ASTRE database

    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 Outcomes (4)

  • Recipient Efficacy (any adverse events)

    During one year

  • Recipient Safety (any adverse events)

    During one year

  • Reconstitution of the T, and B cell populations

    During one year

  • Cost comparison

    During one year

Study Arms (2)

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

Patients in the Thymoglobulin group

Patients in the thymoglobulin group (n=150) will be selected and analyzed retrospectively from the Astre database

Other: Grafalon

Interventions

GrafalonOTHER

None interventional study but there are two groups

Also known as: Thymoglobulin
Patients in the Grafalon groupPatients in the Thymoglobulin group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patient younger than 18 years old
  • Living donor
  • Donor after cardiac death (because the Maastricht 3 donors are authorized recently in France)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CHU Amiens Picardie, Hopital Sud

Amiens, 80054, France

NOT YET RECRUITING

CHU d'Angers

Angers, 49933, France

NOT YET RECRUITING

CHRU de Brest

Brest, 29609, France

RECRUITING

CHU Hopital Clemenceau

Caen, 14033, France

NOT YET RECRUITING

CHU Hopital Gabriel Montpied

Clermont-Ferrand, 63003, France

NOT YET RECRUITING

CHU Dupuytren 2

Limoges, 87000, France

RECRUITING

Hopital Necker Enfant Malade

Paris, 75743, France

NOT YET RECRUITING

CHU La Milétrie

Poitiers, 86021, France

NOT YET RECRUITING

CHU Hopital Maison Blanche

Reims, 51092, France

NOT YET RECRUITING

CHU de Rennes

Rennes, 35033, France

NOT YET RECRUITING

CHU Hopital de Bois Guillaume

Rouen, 76230, France

NOT YET RECRUITING

Hopitaux Universitaires de Strasbourg - Hopital civil

Strasbourg, 67091, France

NOT YET RECRUITING

CHRU de Tours

Tours, 37044, France

NOT YET RECRUITING

MeSH Terms

Interventions

thymoglobulin

Central Study Contacts

Yannick LE MEUR

CONTACT

298-347-074yannick.lemeur@chu-brest.fr

Christelle RATAJCZAK

CONTACT

298-347-061christelle.ratajczak@chu-brest.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

June 24, 2019

Study Start

May 22, 2019

Primary Completion

May 22, 2021

Study Completion

November 22, 2021

Last Updated

July 7, 2020

Record last verified: 2020-06

Locations

FR(13)