Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT02191150
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2014-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Haemodialysis Patients Switching From Aranesp to Biosimilar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-05', 'studyFirstSubmitDate': '2014-07-07', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Subjects with PRCA testing and incidence of neutralizing anti-erythropoietin antibodies', 'timeFrame': 'Duration of 52-week observation period', 'description': 'Pure Red Cell Aplasia (PRCA) test and results'}], 'primaryOutcomes': [{'measure': 'Haemoglobin Concentration', 'timeFrame': 'Duration of observation period -52 weeks', 'description': 'Mean haemoglobin concentration over time'}], 'secondaryOutcomes': [{'measure': 'ESA Doses', 'timeFrame': 'Duration of observation period -52 weeks', 'description': 'Doses of ESA over time.'}, {'measure': 'Dose ratio', 'timeFrame': 'Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)', 'description': 'Dose ratio between the start of the post-switch observation period and pre-switch'}, {'measure': 'Dose ratio', 'timeFrame': 'Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)', 'description': 'Dose ratio between the end of the post-switch observation period and pre-switch'}, {'measure': 'Haemoglobin excursions', 'timeFrame': 'Duration of observation period -52 weeks', 'description': 'Haemoglobin excursions (\\<10/dL and \\>12g/dL)'}, {'measure': 'Haemglobin within range', 'timeFrame': 'Duration of observation period -52 weeks', 'description': 'Haemoglobin in the range 10-12g/dL over time'}, {'measure': 'TSAT, ferritin and albumin values', 'timeFrame': 'Duration of observation period -52 weeks', 'description': 'TSAT, ferritin and albumin over time'}, {'measure': 'Iron Use', 'timeFrame': 'Duration of observation period -52 weeks', 'description': 'Iron use (dose/route) over time'}, {'measure': 'Red cell transfusions (including number of units transfused)', 'timeFrame': 'Duration of observation period -52 weeks', 'description': 'Red cell transfusions (including number of units transfused)'}, {'measure': 'Hospitalisations (including primary cause)', 'timeFrame': 'Duration of observation period -52 weeks', 'description': 'Hospitalisations (including primary cause)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anaemia, Chronic Kidney Disease, Switching, Aranesp, Darbepoetin Alfa, Epoetin Alfa Biosimilars, Haemodialysis.'], 'conditions': ['Anaemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The study will obtain data to show insight into clinical outcomes of patients switching from Darbepoetin Alfa to a epoetin alfa biosimilar.', 'detailedDescription': 'Biosimilars were approved in 2007 by the EMA in EU and in 2010 by the TGA in Australia. This study will look at the retrospective data of patients that have switched from Darbepoetin Alfa to an approved epoetin alfa biosimilar. Data will be collected for the 26 week period prior to switch and a 26 week period post switch to a biosimilar. Data to be collected includes haemoglobin measurements, dose requirements, iron use, any transfusions, hospitalisations and other lab values including TSAT, Ferritin and albumin. Data from the study will be published.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population comprises prevalent haemodialysis (HD) patients treated at EU and Australian dialysis clinics after September 2008. Eligible patients will have received treatment with darbepoetin alfa for at least 26 weeks prior to being converted to an EMA/TGA-approved epoetin alfa biosimilar. At each participating study site, all potentially eligible patients are to be considered for enrolment.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Patients ≥18 years of age\n* Patients with CKD on haemodialysis and fulfilling the following:\n\n * Received HD for at least 26 weeks prior to switching from treatment with darbepoetin alfa to treatment with an EMA/TGA-approved epoetin alfa biosimilar\n * Received darbepoetin alfa treatment i.v. for at least 26 weeks immediately prior to switching to an EMA/TGA-approved epoetin alfa biosimilar (breaks due to treatment being intentionally withheld are permitted)\n * Switched from darbepoetin alfa treatment to an EMA/TGA-approved epoetin alfa biosimilar at least 26 weeks prior to enrolment\n * Received at least one dose of an EMA/TGA-approved epoetin alfa biosimilar after switching from darbepoetin alfa treatment\n* Mean monthly Hb 10-12g/dL in the 12 weeks prior to switch\n* Stable darbepoetin alfa dose (i.e. no more than one increment or decrement of PFS) in the 12 weeks prior to switch\n* Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements\n\nExclusion Criteria:\n\n* Treatment with an ESA other than darbepoetin alfa during the 12 weeks prior to switch to biosimilar\n* More than 14 days' cumulative treatment with short-acting ESA during weeks 26-13 prior to switch to biosimilar\n* Subject received chemotherapy or major surgery during the 26 weeks prior to switch to biosimilar\n* Subject was enrolled in an interventional device or drug study at any time during the 52-week data observation period or within 30 days prior to commencement of the data observation period."}, 'identificationModule': {'nctId': 'NCT02191150', 'acronym': 'SHADE', 'briefTitle': 'Study of Haemodialysis Patients Switching From Aranesp to Biosimilar', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'Retrospective Study of Stable Haemodialysis Patients Switched From Darbepoetin Alfa to Epoetin Alfa Biosimilar', 'orgStudyIdInfo': {'id': '20130300'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Patients with CKD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4560', 'city': 'Nambour', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -26.62613, 'lon': 152.95941}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '8000', 'city': 'Burgas', 'country': 'Bulgaria', 'facility': 'Research Site', 'geoPoint': {'lat': 42.50651, 'lon': 27.46886}}, {'zip': '32657', 'city': 'Lemgo', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.02786, 'lon': 8.89901}}, {'zip': '35423', 'city': 'Lich', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.52085, 'lon': 8.81567}}, {'zip': '32429', 'city': 'Minden', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.28953, 'lon': 8.91455}}, {'zip': '12242', 'city': 'Aigáleo', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98333, 'lon': 23.68333}}, {'zip': '12244', 'city': 'Egaleo, Athens', 'country': 'Greece', 'facility': 'Research Site'}, {'zip': '17676', 'city': 'Kallithea, Athens', 'country': 'Greece', 'facility': 'Research Site'}, {'zip': '41335', 'city': 'Larissa', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '26225', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': '26500', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'Research Site', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': '98057', 'city': 'Milazzo ME', 'country': 'Italy', 'facility': 'Research Site'}, {'zip': '56124', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '89-600', 'city': 'Chojnice', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 53.69554, 'lon': 17.55701}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-954', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '60-355', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '44-200', 'city': 'Rybnik', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.09713, 'lon': 18.54179}}, {'zip': '23007', 'city': 'Jaén', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '49022', 'city': 'Zamora', 'state': 'Castille and León', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.50633, 'lon': -5.74456}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}