Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00815867
Status:
COMPLETED
Last Update Posted:
2016-04-28
First Post:
2008-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C103998', 'term': 'epoetin beta'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-27', 'studyFirstSubmitDate': '2008-12-30', 'studyFirstSubmitQcDate': '2008-12-30', 'lastUpdatePostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'The evolution of renal function', 'timeFrame': '90 days'}, {'measure': 'The survival of patients and grafts', 'timeFrame': '90 days'}, {'measure': 'The time of onset and incidence of acute rejection proved by biopsy', 'timeFrame': '90 days'}, {'measure': 'The correction of anemia', 'timeFrame': '90 days'}, {'measure': 'The need for transfusions', 'timeFrame': '90 days'}, {'measure': 'The need for EPO', 'timeFrame': '90 days'}, {'measure': 'Quality of Life', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['kidney failure', 'kidney transplant', 'graft function', 'haemoglobin', 'epoetin'], 'conditions': ['Kidney Failure']}, 'referencesModule': {'references': [{'pmid': '36791280', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '20642691', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.', 'detailedDescription': 'French study, prospective, multicenter, open, randomized into two parallel groups:\n\nGroup A: NeoRecormon ® 30000 UI: 4 injections Group B: control group without administration of the medical product\n\nPeriod of recruitment: 18 months Duration of participation of each patient: 90 days Total duration of the test: 21 months.\n\nMain objective : Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant.\n\nSecondary objectives:\n\nComparing the 2 groups at all times J0 to J90:\n\n* The evolution of renal function\n* The survival of patients and grafts\n* The time of onset and incidence of acute rejection proved by biopsy\n* The correction of anemia\n* The need for transfusions\n* The need for EPO\n* Quality of Life\n* The safety processing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males anf Females aged between 18 and 75\n* Patients having given their written consent\n* Patient determined to participate in the test and to respect the requirements\n* Patient covered by a social insurance\n* Patient to be kidney transplanted (from a cadaveric donor)\n* Patient benefiting from the 1st or 2nd kidney transplant\n* Patient formerly treated by peritoneal dialysis or hemodialysis\n* 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)\n* Patient to receive treatment with basiliximab, mycophenolate mofetil, tacrolimus and corticosteroid\n\nExclusion Criteria:\n\n* Patient Pregnant or nursing\n* Patient with a disability that does not ensure the good understanding of the study and its imperatives , or patient having dependency (alcohol, drugs)\n* Patient receiving doses of epoetin beta or alpha\\> 30,000 IU / week or darbepoetin\\> 150 microg / week before transplanting\n* Patient who has participated in a clinical trial in the last month or currently included in another test\n* Patient in safeguarding justice, guardianship or trusteeship\n* Patient receiving a third transplant or hyper immune or who have a positive historic cross-match\n* Patient receiving a preemptive transplant\n* graft from a living donor\n* graft with 3 or more arteries\n* Multi-Organ Transplantation\n* Patient with heart failure stage\\> III\n* 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\n* Patients with active viral infection: hepatitis B, C (PCR + only) or HIV\n* Patient with a history of anemia from erythroblastopenia\n* Patient receiving anticoagulant treatment(AVK) before renal transplantation and to be continued after transplant\n* Patient with a preoperative rate Hb\\> 14 g / dL (before ultrafiltration)\n* A patient with known hypersensitivity to the active substance or to any of the excipients, or to benzoic acid\n* Patients with poorly controlled hypertension in the weeks before transplantation (Diastolic Blood Pressure ≥ 110 mm Hg with more than 3 antihypertensive drugs)'}, 'identificationModule': {'nctId': 'NCT00815867', 'acronym': 'Neo-PDGF', 'briefTitle': 'Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant', 'orgStudyIdInfo': {'id': 'PI07-PR-CHOUKROUN'}, 'secondaryIdInfos': [{'id': '2007/14 CPP'}, {'id': '2007-002562-35 EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Patient will receive Epoetin Beta', 'interventionNames': ['Drug: epoetin beta (NeoRecormon ®)']}, {'type': 'NO_INTERVENTION', 'label': 'B'}], 'interventions': [{'name': 'epoetin beta (NeoRecormon ®)', 'type': 'DRUG', 'otherNames': ['Neorecormon'], 'description': 'comparison of administration of high dosage of epoetin vs no administration of epoetin\n\n30000 UI: 4 injections', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': 'Amiens hospital', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'LA CAVALE BLANCHE Hospital', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'MONDOR Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'MICHALLON Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Kremlin Bicêtre Hospital', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '59 000', 'city': 'Lille', 'country': 'France', 'facility': 'ALBERT CALMETTE Hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes, Hotel-Dieu Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'CHU Nice, Pasteur Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Georges Pompidou European Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'TENON Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75', 'city': 'Paris', 'country': 'France', 'facility': 'Necker Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'LA MILETRIE Hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'MAISON BLANCHE Hospital', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76230', 'city': 'Rouen', 'country': 'France', 'facility': 'Bois Guillaume Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'facility': 'FOCH Hospital', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'RANGUEIL Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'BRETONNEAU Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'CHOUKROUN Gabriel, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}, {'name': 'MARTINEZ Franck, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Necker Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}