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| ID | Type | Description | Link |
|---|---|---|---|
| 2007/14 CPP | |||
| 2007-002562-35 EudraCT |
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.
French study, prospective, multicenter, open, randomized into two parallel groups:
Group A: NeoRecormon ® 30000 UI: 4 injections Group B: control group without administration of the medical product
Period of recruitment: 18 months Duration of participation of each patient: 90 days Total duration of the test: 21 months.
Main objective : Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant.
Secondary objectives:
Comparing the 2 groups at all times J0 to J90:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Patient will receive Epoetin Beta |
|
| B | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epoetin beta (NeoRecormon ®) | Drug | comparison of administration of high dosage of epoetin vs no administration of epoetin 30000 UI: 4 injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The evolution of renal function | 90 days | |
| The survival of patients and grafts | 90 days | |
| The time of onset and incidence of acute rejection proved by biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CHOUKROUN Gabriel, Ph D | CHU Amiens | Principal Investigator |
| MARTINEZ Franck, Ph D | Necker Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens hospital | Amiens | 80000 | France | |||
| LA CAVALE BLANCHE Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3. | |
| 20642691 | Derived | Martinez F, Kamar N, Pallet N, Lang P, Durrbach A, Lebranchu Y, Adem A, Barbier S, Cassuto-Viguier E, Glowaki F, Le Meur Y, Rostaing L, Legendre C, Hermine O, Choukroun G; NeoPDGF Study Investigators. High dose epoetin beta in the first weeks following renal transplantation and delayed graft function: Results of the Neo-PDGF Study. Am J Transplant. 2010 Jul;10(7):1695-700. doi: 10.1111/j.1600-6143.2010.03142.x. |
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| 90 days |
| The correction of anemia | 90 days |
| The need for transfusions | 90 days |
| The need for EPO | 90 days |
| Quality of Life | 90 days |
| Brest |
| 29200 |
| France |
| MONDOR Hospital | Créteil | 94010 | France |
| MICHALLON Hospital | Grenoble | 38000 | France |
| Kremlin Bicêtre Hospital | Le Kremlin-Bicêtre | 94275 | France |
| ALBERT CALMETTE Hospital | Lille | 59 000 | France |
| CHU Nantes, Hotel-Dieu Hospital | Nantes | 44093 | France |
| CHU Nice, Pasteur Hospital | Nice | 06000 | France |
| Georges Pompidou European Hospital | Paris | 75015 | France |
| TENON Hospital | Paris | 75020 | France |
| Necker Hospital | Paris | 75 | France |
| LA MILETRIE Hospital | Poitiers | 86000 | France |
| MAISON BLANCHE Hospital | Reims | 51100 | France |
| Bois Guillaume Hospital | Rouen | 76230 | France |
| FOCH Hospital | Suresnes | 92151 | France |
| RANGUEIL Hospital | Toulouse | 31000 | France |
| BRETONNEAU Hospital | Tours | 37044 | France |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C103998 | epoetin beta |
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