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Comparison Thymoglobulin® and Grafalon® (THYGRET)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Renal Transplantation | Other: Grafalon |
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 |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Other |
| Time Perspective: | Other |
| Official Title: | Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I |
| Actual Study Start Date : | May 22, 2019 |
| Estimated Primary Completion Date : | May 22, 2021 |
| Estimated Study Completion Date : | November 22, 2021 |
| 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 Name: 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 Name: Thymoglobulin
|
- 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
- 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)
- 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)
- 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
- Cost comparison [ Time Frame: During one year ]Hospitals costs at 1 year months (including re-hospitalisation costs)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
| Contact: Yannick LE MEUR | 298-347-074 | yannick.lemeur@chu-brest.fr | |
| Contact: Christelle RATAJCZAK | 298-347-061 | christelle.ratajczak@chu-brest.fr |
| France | |
| CHU Amiens Picardie, Hopital Sud | Not yet recruiting |
| Amiens, France, 80054 | |
| Contact: Pierre-François Westeel westeel.pierre-françois@chu-amiens.fr | |
| CHU d'Angers | Not yet recruiting |
| Angers, France, 49933 | |
| Contact: Agnès Duveau agnes.duveau@chu-angers.fr | |
| CHRU de Brest | Recruiting |
| Brest, France, 29609 | |
| Contact: Yannick Le Meur yannick.lemeur@chu-brest.fr | |
| CHU Hopital Clemenceau | Not yet recruiting |
| Caen, France, 14033 | |
| Contact: Nicolas Bouvier bouvier-n@chu-caen.fr | |
| CHU Hopital Gabriel Montpied | Not yet recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Anne-Elisabeth Heng aheng@chu-clermontferrand.fr | |
| CHU Dupuytren 2 | Recruiting |
| Limoges, France, 87000 | |
| Contact: Jean-Philippe Rerolle jean-philippe.rerolle@chu-limoges.fr | |
| Hopital Necker Enfant Malade | Not yet recruiting |
| Paris, France, 75743 | |
| Contact: Dany Anglicheau dany.anglicheau@nck.aphp.fr | |
| CHU La Milétrie | Not yet recruiting |
| Poitiers, France, 86021 | |
| Contact: Antoine Thierry a.thierry@chu-poitiers.fr | |
| CHU Hopital Maison Blanche | Not yet recruiting |
| Reims, France, 51092 | |
| Contact: Charlotte Colosio ccolosio@chu-reims.fr | |
| CHU de Rennes | Not yet recruiting |
| Rennes, France, 35033 | |
| Contact: Léonard Golbin leonard.golbin@chu-rennes.fr | |
| CHU Hopital de Bois Guillaume | Not yet recruiting |
| Rouen, France, 76230 | |
| Contact: Isabelle Etienne isabelle.etienne@chu-rouen.fr | |
| Hopitaux Universitaires de Strasbourg - Hopital civil | Not yet recruiting |
| Strasbourg, France, 67091 | |
| Contact: Sophie Caillard sophie.caillard@chu-strasbourg.fr | |
| CHRU de Tours | Not yet recruiting |
| Tours, France, 37044 | |
| Contact: Matthias Buchler buchler@med.univ-tours.fr | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 28, 2019 | ||||||||
| First Posted Date | June 24, 2019 | ||||||||
| Last Update Posted Date | July 7, 2020 | ||||||||
| Actual Study Start Date | May 22, 2019 | ||||||||
| Estimated Primary Completion Date | May 22, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Comparison Thymoglobulin® and Grafalon® | ||||||||
| Official Title | Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I | ||||||||
| 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. |
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| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Other |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition | Renal Transplantation | ||||||||
| Intervention | Other: Grafalon
None interventional study but there are two groups
Other Name: Thymoglobulin
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
300 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | November 22, 2021 | ||||||||
| Estimated Primary Completion Date | May 22, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
age (donor and recipient) gender indication (immunological indication versus DFG) CMV status Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03996278 | ||||||||
| Other Study ID Numbers | 29BRC19.0018 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | University Hospital, Brest | ||||||||
| Study Sponsor | University Hospital, Brest | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | University Hospital, Brest | ||||||||
| Verification Date | June 2020 | ||||||||
