Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
NCT ID: NCT00815867
Last Updated: 2016-04-28
Study Results
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Basic Information
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2007-10-31
2009-09-30
Brief Summary
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Detailed Description
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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:
* The evolution of renal function
* The survival of patients and grafts
* The time of onset and incidence of acute rejection proved by biopsy
* The correction of anemia
* The need for transfusions
* The need for EPO
* Quality of Life
* The safety processing
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Patient will receive Epoetin Beta
epoetin beta (NeoRecormon ®)
comparison of administration of high dosage of epoetin vs no administration of epoetin
30000 UI: 4 injections
B
No interventions assigned to this group
Interventions
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epoetin beta (NeoRecormon ®)
comparison of administration of high dosage of epoetin vs no administration of epoetin
30000 UI: 4 injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients having given their written consent
* Patient determined to participate in the test and to respect the requirements
* Patient covered by a social insurance
* Patient to be kidney transplanted (from a cadaveric donor)
* Patient benefiting from the 1st or 2nd kidney transplant
* Patient formerly treated by peritoneal dialysis or hemodialysis
* Patient receiving a graft with risk of delayed graft function (score\> 7 combining age of the donor, ischemia time, receiver ethnicity and cause of death)
* Patient to receive treatment with basiliximab, mycophenolate mofetil, tacrolimus and corticosteroid
Exclusion Criteria
* Patient with a disability that does not ensure the good understanding of the study and its imperatives , or patient having dependency (alcohol, drugs)
* Patient receiving doses of epoetin beta or alpha\> 30,000 IU / week or darbepoetin\> 150 microg / week before transplanting
* Patient who has participated in a clinical trial in the last month or currently included in another test
* Patient in safeguarding justice, guardianship or trusteeship
* Patient receiving a third transplant or hyper immune or who have a positive historic cross-match
* Patient receiving a preemptive transplant
* graft from a living donor
* graft with 3 or more arteries
* Multi-Organ Transplantation
* Patient with heart failure stage\> III
* Patients with unstable ischemic heart disease, or have had a major coronary event less than 6 months, stroke or TIA \<6 months or symptomatic arteritis of lower limbs stage ≥ 3
* Patients with active viral infection: hepatitis B, C (PCR + only) or HIV
* Patient with a history of anemia from erythroblastopenia
* Patient receiving anticoagulant treatment(AVK) before renal transplantation and to be continued after transplant
* Patient with a preoperative rate Hb\> 14 g / dL (before ultrafiltration)
* A patient with known hypersensitivity to the active substance or to any of the excipients, or to benzoic acid
* Patients with poorly controlled hypertension in the weeks before transplantation (Diastolic Blood Pressure ≥ 110 mm Hg with more than 3 antihypertensive drugs)
18 Years
75 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Centre Hospitalier Universitaire, Amiens
OTHER
Responsible Party
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Principal Investigators
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CHOUKROUN Gabriel, Ph D
Role: PRINCIPAL_INVESTIGATOR
CHU Amiens
MARTINEZ Franck, Ph D
Role: PRINCIPAL_INVESTIGATOR
Necker Hospital
Locations
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Amiens hospital
Amiens, , France
LA CAVALE BLANCHE Hospital
Brest, , France
MONDOR Hospital
Créteil, , France
MICHALLON Hospital
Grenoble, , France
Kremlin Bicêtre Hospital
Le Kremlin-Bicêtre, , France
ALBERT CALMETTE Hospital
Lille, , France
CHU Nantes, Hotel-Dieu Hospital
Nantes, , France
CHU Nice, Pasteur Hospital
Nice, , France
Georges Pompidou European Hospital
Paris, , France
TENON Hospital
Paris, , France
Necker Hospital
Paris, , France
LA MILETRIE Hospital
Poitiers, , France
MAISON BLANCHE Hospital
Reims, , France
Bois Guillaume Hospital
Rouen, , France
FOCH Hospital
Suresnes, , France
RANGUEIL Hospital
Toulouse, , France
BRETONNEAU Hospital
Tours, , France
Countries
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References
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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.
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.
Other Identifiers
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2007/14 CPP
Identifier Type: -
Identifier Source: secondary_id
2007-002562-35 EudraCT
Identifier Type: -
Identifier Source: secondary_id
PI07-PR-CHOUKROUN
Identifier Type: -
Identifier Source: org_study_id
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