Renal TransplantationTHYGRETNCT03996278
Comparison Thymoglobulin® and Grafalon®
An observational study of Renal Transplantation, run by University Hospital, Brest at 13 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Grafalon
- How many people
- 300 participants
- Where
- 13 sitesFrance
- Study dates
- 22 May 2019to 22 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient younger than 18 years old
- Living donor
- Donor after cardiac death (because the Maastricht 3 donors are authorized recently in France)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites, 13 recruiting
- Not yet recruiting
CHU Amiens Picardie, Hopital Sud
Amiens, 80054
Pierre-François Westeel, westeel.pierre-françois@chu-amiens.fr
- Not yet recruiting
CHU d'Angers
Angers, 49933
Agnès Duveau, agnes.duveau@chu-angers.fr
- Recruiting
CHRU de Brest
Brest, 29609
Yannick Le Meur, yannick.lemeur@chu-brest.fr
- Not yet recruiting
CHU Hopital Clemenceau
Caen, 14033
Nicolas Bouvier, bouvier-n@chu-caen.fr
- Not yet recruiting
CHU Hopital Gabriel Montpied
Clermont-Ferrand, 63003
Anne-Elisabeth Heng, aheng@chu-clermontferrand.fr
- Recruiting
CHU Dupuytren 2
Limoges, 87000
Jean-Philippe Rerolle, jean-philippe.rerolle@chu-limoges.fr
- Not yet recruiting
Hopital Necker Enfant Malade
Paris, 75743
Dany Anglicheau, dany.anglicheau@nck.aphp.fr
- Not yet recruiting
CHU La Milétrie
Poitiers, 86021
Antoine Thierry, a.thierry@chu-poitiers.fr
- Not yet recruiting
CHU Hopital Maison Blanche
Reims, 51092
Charlotte Colosio, ccolosio@chu-reims.fr
- Not yet recruiting
CHU de Rennes
Rennes, 35033
Léonard Golbin, leonard.golbin@chu-rennes.fr
- Not yet recruiting
CHU Hopital de Bois Guillaume
Rouen, 76230
Isabelle Etienne, isabelle.etienne@chu-rouen.fr
- Not yet recruiting
Hopitaux Universitaires de Strasbourg - Hopital civil
Strasbourg, 67091
Sophie Caillard, sophie.caillard@chu-strasbourg.fr
- Not yet recruiting
CHRU de Tours
Tours, 37044
Matthias Buchler, buchler@med.univ-tours.fr
About this study
Official title: 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.
Read the 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
- Renal Transplantation
- Being tested
- Grafalon
- Keywords
- THYMOGLOBULINE®, GRAFALON®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrafalonOther
Also called Thymoglobulin
None interventional study but there are two groups
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Grafalon | |
| Patients in the Thymoglobulin group | Patients in the thymoglobulin group (n=150) will be selected and analyzed retrospectively from the Astre database Receives: Other: Grafalon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During one year
Secondary outcomes (4)
Recipient Efficacy (any adverse events)
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)
Measured: During one year
Recipient Safety (any adverse events)
Comparison during the first year between the two groups for various infections (virus, bacteria, fungi), hematological adverse event (SAE or not)
Measured: During one year
Reconstitution of the T, and B cell populations
Reconstitution of the T, and B cell populations at D0, D7, M3, M12
Measured: During one year
Cost comparison
Hospitals costs at 1 year months (including re-hospitalisation costs)
Measured: During one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start22 May 2019
- Primary completion22 May 2021 (estimated)
- Study completion22 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996278
- Sponsor's protocol ID
- 29BRC19.0018
- Acronym
- THYGRET
- Status last verified
- Jun 2020
- First submitted
- 28 May 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I
- ClinicalTrials.gov ID
- NCT03996278
- Acronym / sponsor ID
- THYGRET / 29BRC19.0018
- Conditions
- Renal Transplantation
- Keywords
- THYMOGLOBULINE®, GRAFALON®
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 22 May 2021 (estimated)
- Study completion
- 22 Nov 2021 (estimated)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in the Grafalon group | – | Other: GrafalonPatients in the Grafalon group (n=150) will be followed prospectively and data prospectively collected thanks to the Astre database |
| Patients in the Thymoglobulin group | – | Other: GrafalonPatients in the thymoglobulin group (n=150) will be selected and analyzed retrospectively from the Astre database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patient younger than 18 years old
- Living donor
- Donor after cardiac death (because the Maastricht 3 donors are authorized recently in France)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GrafalonAlso: ThymoglobulinNone interventional study but there are two groups | Other | Patients in the Grafalon group, Patients in the Thymoglobulin group |
Primary outcome
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
4 secondary outcomes
Recipient Efficacy (any adverse events)
Time frame: During one year
Recipient Safety (any adverse events)
Time frame: During one year
Reconstitution of the T, and B cell populations
Time frame: During one year
Cost comparison
Time frame: During one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplantation, run by University Hospital, Brest at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick LE MEUR (298-347-074, yannick.lemeur@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison adverse events of the 2 ATGs and data collected thanks to the ASTRE database (time frame: During one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.