Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-27 @ 7:58 AM
Study NCT ID:
NCT00111995
Status:
COMPLETED
Last Update Posted:
2008-08-08
First Post:
2005-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Aranesp® for the Treatment of Anemia in African-American Subjects With Chronic Renal Failure (CRF) Receiving Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin 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': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'statusVerifiedDate': '2008-08', 'lastUpdateSubmitDate': '2008-08-07', 'studyFirstSubmitDate': '2005-05-27', 'studyFirstSubmitQcDate': '2005-05-27', 'lastUpdatePostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean hemoglobin level during the evaluation period'}], 'secondaryOutcomes': [{'measure': 'The nature, frequency, severity, relationship to treatment, and outcome of adverse events with specific attention to hypertensive events'}]}, 'conditionsModule': {'keywords': ['Chronic Renal Failure (CRF)', 'Anemia'], 'conditions': ['Chronic Renal Failure', 'Anemia']}, '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.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_33_NESP_20010125.pdf', 'label': 'To access clinical trial results information click on this link'}, {'url': 'http://www.aranesp.com/', 'label': 'FDA-approved Drug Labeling'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the hemoglobin response to Aranesp® (darbepoetin alfa) in black subjects (African-Americans) with chronic renal failure (CRF) receiving hemodialysis and to examine the safety profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - Diagnosis of CRF and 3 times weekly prescribed hemodialysis treatments for at least 8 weeks before signing informed consent - No planned change in dialysis modality or schedule - Black (as indicated on the Chronic Medical Evidence Disease Report, CMMS Form 2728) - Hemoglobin 9.5 to 12.5 g/dL on 2 consecutive occasions during the screening period (1 week + 2 days apart) and baseline hemoglobin level of 9.5 - 12.5 g/dL (defined as the mean of all measurements taken during the screening and baseline periods) - Transferrin saturation greater than or equal to 20% but less than or equal to 50% - Stable rHuEPO therapy given 3 times per week by intravenous (IV) route of administration for 6 weeks before randomization (stable is defined as less than or equal to 25% change in prescribed dose over 6 weeks, same route of administration, and no more than 1 missed or withheld dose during each of the two 3-week periods before randomization) Exclusion Criteria: - Scheduled for a living-related or living non-related donor transplant - rHuEPO dose greater than 40,000 units weekly - Uncontrolled hypertension (postdialysis diastolic blood pressure greater than 105 mmHg and/or systolic blood pressure greater than 180 mmHg on more than 1 occasion as noted in the collected blood pressure measurements during the screening/baseline period) - Congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV) - Major surgery (excluding vascular access surgery) within 8 weeks before signing informed consent and during screening/baseline - Clinical evidence of active inflammatory disease requiring cyclophosphamide, azathioprine, prednisone or other immunosuppressive therapy within 8 weeks before signing the informed consent and during screening/baseline - Currently (at the signing of the informed consent) receiving antibiotics for a systemic infection and during screening/baseline - Known positivity for HIV antibody or hepatitis B surface antigen - Grand mal seizures within the last year - Clinical evidence of current malignancy (other than non-melanomatous skin malignancy), and/or receiving chemotherapy, and/or radiation therapy for malignancies within 8 weeks of signing the informed consent and during screening/baseline - Active systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia) within 8 weeks of signing the informed consent and during screening/baseline - Clinical evidence of severe hyperparathyroidism (parathyroid hormone \\[PTH\\] level greater than 1500 pg/mL or biopsy-proven bone marrow fibrosis) at last measurement - ALT or AST greater than 2x the upper limit of the normal range - Red blood cell transfusions within 8 weeks before signing the informed consent and during screening/baseline - Known hypersensitivity to human serum albumin (HSA)'}, 'identificationModule': {'nctId': 'NCT00111995', 'briefTitle': 'Evaluating Aranesp® for the Treatment of Anemia in African-American Subjects With Chronic Renal Failure (CRF) Receiving Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-Blind Study Comparing Aranesp® (Darbepoetin Alfa) and Recombinant Human Erythropoietin (rHuEPO) in the Treatment of Anemia in African-American Subjects With Chronic Renal Failure (CRF) Receiving Hemodialysis', 'orgStudyIdInfo': {'id': '20010125'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aranesp®', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}