Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-28 @ 8:40 AM
Study NCT ID:
NCT00676234
Status:
COMPLETED
Last Update Posted:
2009-06-30
First Post:
2008-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Human Erythropoietin Use in Intensive Care Unit (ICU) Patients: Does it Prevent Acute Renal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D000068817', 'term': 'Epoetin Alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-26', 'studyFirstSubmitDate': '2008-05-07', 'studyFirstSubmitQcDate': '2008-05-09', 'lastUpdatePostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection', 'timeFrame': '4 days'}], 'secondaryOutcomes': [{'measure': 'mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection', 'timeFrame': '4 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['erythropoietin'], 'conditions': ['Acute Renal Failure']}, 'referencesModule': {'references': [{'pmid': '39301879', 'type': 'DERIVED', 'citation': 'Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.'}, {'pmid': '23033926', 'type': 'DERIVED', 'citation': 'de Seigneux S, Ponte B, Weiss L, Pugin J, Romand JA, Martin PY, Saudan P. Epoetin administrated after cardiac surgery: effects on renal function and inflammation in a randomized controlled study. BMC Nephrol. 2012 Oct 3;13:132. doi: 10.1186/1471-2369-13-132.'}]}, 'descriptionModule': {'briefSummary': 'Pilot study aiming to assess the effect of two doses of rhu EPO on urine NGAL concentration and on serum cystatin C and creatinine levels in critically ill patients at risk of ARF.', 'detailedDescription': "Research plan Open-label randomized trial Twelve months duration trial Setting: Medical and Surgical Intensive Care Unit of the University Hospitals of Geneva Start of trial: Mid-May 2008\n\nPatients randomly allocated to 2 treatment groups (20 patients per group), or a control group (40 patients):\n\n* Group 1: control group (40 patients)\n* Group 2 : 20000 IU rhu Epo (20 patients) administered by the i.v. route\n* Group 3 : 40000 IU rhu Epo (20 patients) administered by the i.v. route\n\n3.2. Trial design Day 0 Consent form signed Patients randomly allocated to control or treatment groups (20000 and 40000 IU) Serum Cystatin C determination Serum Creatinine determination Urinary NGAL determination Administration of intravenous rhu Epo on Day 0 or no Epo (control group) Day 2 At 48 hr after rhu EPO injection, samples will be taken for\n\n* Serum Cystatin C determination\n* Serum Creatinine determination\n* Urinary NGAL determination Day 4 At 96 hr after rhu EPO injection, samples will be taken for\n* Serum Cystatin C determination\n* Serum Creatinine determination\n* Urinary NGAL determination\n\nStopping rules\n\nThe trial for an individual subject, parts of the trial or the entire trial will be stopped when:\n\n* at Day 4 for an individual subject\n* after enrollment of 80 patients\n\nTreatment The treatment will consist of intravenous (i.v.) injections of recombinant human erythropoietin (r-hu-EPO). The trial medication will be provided by JANSSEN-CILAG AG. The brand name is EPREX® which is epoietinum-alpha in sterile buffered solution for i.v. or s.c. injection.\n\nPatient group 1 will not receive EPO treatment. Patient group 2 will receive 20'000 U of rhu EPO and patient group 3 will receive 40'000 U of rhu EPO (i.v. route)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at risks for acute tubular necrosis (patients with mechanical ventilation, patients with sepsis, in the post-operative state, with hemodynamic impairment or with previous chronic renal failure.\n* Consent form signed\n\nExclusion Criteria:\n\n* Patients with malignant hypertension\n* Patients with systolic BP \\> 150 mmHg at enrollment\n* Patients with Hb level \\> 120g/L\n* Patients with acute coronaropathy\n* Pregnancy\n* Patients with urine output \\< 600 ml/12 h'}, 'identificationModule': {'nctId': 'NCT00676234', 'briefTitle': 'Recombinant Human Erythropoietin Use in Intensive Care Unit (ICU) Patients: Does it Prevent Acute Renal Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?', 'orgStudyIdInfo': {'id': '2008-11021991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Administration of intravenous rhu Epo on Day 0', 'interventionNames': ['Drug: epoetinum']}], 'interventions': [{'name': 'epoetinum', 'type': 'DRUG', 'otherNames': ['Eprex'], 'description': 'Administration of intravenous rhu Epo on Day 0 20000 IU rhu Epo (20 patients) administered by the i.v. route 40000 IU rhu Epo (20 patients) administered by the i.v. route', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Nephrology Unit, Geneva University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Patrick Saudan, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nephrology Unit Geneva University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr P. Saudan', 'oldOrganization': 'Nephrology Unit'}}}}