Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT00869856
Status:
WITHDRAWN
Last Update Posted:
2015-06-02
First Post:
2009-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Italy', 'Poland', 'Russia', 'Serbia', 'Slovakia', 'Ukraine']}, '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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'investigation of adverse events in a related clinical study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-01', 'studyFirstSubmitDate': '2009-03-25', 'studyFirstSubmitQcDate': '2009-03-25', 'lastUpdatePostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hemoglobin level', 'timeFrame': '36 weeks'}], 'secondaryOutcomes': [{'measure': 'To document the safety and lack of immunogenicity of HX575. To determine the optimal dosing regimen of HX575 s.c. administration.', 'timeFrame': '36 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment associated with CRI'], 'conditions': ['Anemia', 'Chronic Renal Insufficiency']}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety switch study involving 500 CKD subjects suffering from anemia and treated previously with a stable dose of ESA s.c.\n\nCorrection of anemia will be maintained by s.c. administration of HX575 in two frequencies (i.e. qw and q2w), in order to maintain an Hb target range of 10.0-12.0 g/dL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female CKD subjects with or without dialysis treatment\n* Age \\> 18 years\n* Subjects under documented stable maintenance therapy with ESA, s.c. at least once per week and in accordance with the relevant SmPC, for at least 3 months with a total weekly dose of ≤ 300 IU/kg/week\n* Subjects with controlled symptomatic anemia, defined as mean Hb level between 10.0 g/dL and 12.0 g/dL, based on four Hb measurements during the four-week baseline period\n* Adequate iron status, serum ferritin ≥ 100 µg/L or transferrin saturation ≥ 20%\n* Confirmed negative anti-EPO antibody assay from sample taken at screening visit -4\n\nExclusion Criteria:\n\n* Systemic cyclosporine\n* History of PRCA or aplastic anemia\n* History of anti-EPO antibodies\n* Uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT00869856', 'acronym': 'SWEEP', 'briefTitle': 'Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'An Open Label, Single-arm, Baseline-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 Administered Once a Week (qw) and Once Every Two Weeks (q2w) in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Subjects', 'orgStudyIdInfo': {'id': 'HX575-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'HX575, EPO Hexal', 'interventionNames': ['Drug: HX575 solution for s.c. administration']}], 'interventions': [{'name': 'HX575 solution for s.c. administration', 'type': 'DRUG', 'description': 'Containing different strengths of epoetin alfa (1 to 10 KIU), s.c. injection, 1x per week (qw) or 1x every two weeks (q2w), injection into abdomen or upper thigh', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5300', 'city': 'Gabrovo', 'country': 'Bulgaria', 'facility': 'MHAT "Dr. Tota Venkova"', 'geoPoint': {'lat': 42.87419, 'lon': 25.31823}}, {'zip': '4400', 'city': 'Pazardzhik', 'country': 'Bulgaria', 'facility': 'MHAT Pazardzhik', 'geoPoint': {'lat': 42.19934, 'lon': 24.33318}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MHAT"Sveti Ivan Rilski"', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '9000', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'MHAT "Sveta Anna"', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '33077', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Polyclinique de Bordeaux-Nord', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Limoges, Hôpital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '64732', 'city': 'Bad König', 'country': 'Germany', 'facility': 'KfH Nierenzentrum', 'geoPoint': {'lat': 49.7432, 'lon': 9.0075}}, {'zip': '12045', 'city': 'Berlin', 'country': 'Germany', 'facility': 'KfH Nierenzentrum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '23538', 'city': 'Essen', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '68309', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '55232', 'city': 'Slzrx', 'country': 'Germany', 'facility': 'Gesundheitszentrum Alzey Internistische Gemeinschaftspraxis'}, {'zip': '69469', 'city': 'Weinheim', 'country': 'Germany', 'facility': 'Nierenzentrum Weinheim Kreiskrankenhaus Weinheim', 'geoPoint': {'lat': 49.54887, 'lon': 8.66697}}, {'zip': '010731', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Clinic de Nefrologie Dr. Carol Davila', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '050098', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Universitar de Urgenta Bucuresti', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '330084', 'city': 'Deva', 'country': 'Romania', 'facility': 'Spitalul Judetean de Urgenta Deva', 'geoPoint': {'lat': 45.88333, 'lon': 22.9}}, {'zip': '410169', 'city': 'Oradea', 'country': 'Romania', 'facility': 'Spitalul Clinic Municipal "Dr. Gavril Curteanu"', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'zip': '300736', 'city': 'Timișoara', 'country': 'Romania', 'facility': 'Spitalul Clinic Judetean Timisoara', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '28222', 'city': 'Majadahonda', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Hospital de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'overallOfficials': [{'name': 'Karsten Roth', 'role': 'STUDY_CHAIR', 'affiliation': 'Hexal AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sandoz', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}