Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-02 @ 1:03 AM
Study NCT ID:
NCT03787368
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2018-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
End-stage Renal Disease (ESRD) Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000657125', 'term': 'osocimab'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Patients, investigators, and all other site staff will remain blinded for the administered BAY1213790 or placebo, with the exception of the unblinded pharmacist or specifically dedicated site personnel.The sponsor will be not be blinded. Bioanalysis of plasma concentrations and PD parameters, as well as the evaluation of results will be performed in a non-blinded fashion.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2018-12-24', 'studyFirstSubmitQcDate': '2018-12-24', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of major and CRNM bleeding events', 'timeFrame': 'Approx. 4 weeks (Before study drug or placebo administration)', 'description': 'CRNM bleeding: Clinically Relevant Non-Major bleeding'}, {'measure': 'Number of major and CRNM bleeding events', 'timeFrame': 'Approx. 4 weeks (After study drug or placebo administration)'}], 'secondaryOutcomes': [{'measure': 'AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)', 'timeFrame': 'Approx. 5 months (Pre-dose to follow up)', 'description': 'AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose'}, {'measure': 'aPTT will be measured via the kaolin-trigger method (clotting assay)', 'timeFrame': 'Approx. 6 months (Before study drug or placebo administration to follow up)', 'description': 'aPTT: activated Partial Thromboplastin Time'}, {'measure': 'Factor XI activity will be assessed with an aPTT-based coagulation test using FXI', 'timeFrame': 'Approx. 6 months (Before study drug or placebo administration to follow up)', 'description': 'FXI: Factor XI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['End-stage renal disease patients undergoing hemodialysis'], 'conditions': ['Renal Dialysis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety of two different doses of a drug called BAY1213790 and how well it is tolerated in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD). Approximately 40, with up to 60 study patients will take part in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Male and female patients between 18 and 80 years of age.\n* ESRD on hemodialysis (including hemodiafiltration) for at least 3 months\n* Life expectancy of \\> 6 months\n* Women of non-childbearing potential\n\nExclusion Criteria:\n\n* High risk for clinically significant bleeding\n* Acute renal failure\n* Planned major surgery in the next 7 months from randomization\n* Concomitant use of oral anticoagulant therapy or antiplatelet therapy\n* Documented thrombotic event in the past 6 months'}, 'identificationModule': {'nctId': 'NCT03787368', 'briefTitle': 'End-stage Renal Disease (ESRD) Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Observer-blind, Multi-center, Placebo-controlled, Parallel Group Study to Assess the Safety and Tolerability and to Characterize the Pharmacokinetics and the Pharmacodynamics of Different Doses of BAY1213790 in Patients With End-stage Renal Disease Undergoing Hemodialysis', 'orgStudyIdInfo': {'id': '20046'}, 'secondaryIdInfos': [{'id': '2018-003109-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 of BAY1213790', 'description': 'Single intravenous infusion BAY1213790 (Dose 1)', 'interventionNames': ['Drug: BAY1213790']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 of BAY1213790', 'description': 'Single intravenous infusion BAY1213790 (Dose 2)', 'interventionNames': ['Drug: BAY1213790']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single intravenous infusion placebo', 'interventionNames': ['Drug: 0.9% sodium chloride solution']}], 'interventions': [{'name': 'BAY1213790', 'type': 'DRUG', 'description': 'Single intravenous infusion of BAY1213790 (Two different doses)', 'armGroupLabels': ['Dose 1 of BAY1213790', 'Dose 2 of BAY1213790']}, {'name': '0.9% sodium chloride solution', 'type': 'DRUG', 'description': 'Single intravenous infusion of Placebo (0.9% sodium chloride solution)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'California Institute of Renal Research - Chula Vista', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Clinical Research, LLC', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '60643', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research by Design, LLC', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Renal and Transplant Associates of New England, PC', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '6042', 'city': 'Lodelinsart', 'state': 'Hainaut', 'country': 'Belgium', 'facility': 'CHU de Charleroi Hôpital civil', 'geoPoint': {'lat': 50.43138, 'lon': 4.44886}}, {'zip': '1090', 'city': 'Bruxelles - Brussel', 'country': 'Belgium', 'facility': 'UZ Brussel'}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2795-53', 'city': 'Carnaxide', 'state': 'Lisbon District', 'country': 'Portugal', 'facility': 'CHLO - Hospital Santa Cruz', 'geoPoint': {'lat': 38.72706, 'lon': -9.24671}}, {'zip': '2750-663', 'city': 'Cascais', 'state': 'Lisbon District', 'country': 'Portugal', 'facility': 'Pluribus Dialise - Cascais (DaVita)', 'geoPoint': {'lat': 38.69681, 'lon': -9.42147}}, {'zip': '2350-754', 'city': 'Torres Novas', 'state': 'Santarém District', 'country': 'Portugal', 'facility': 'CHMT - Hospital Rainha Santa Isabel', 'geoPoint': {'lat': 39.47581, 'lon': -8.54348}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Ciutat Sanitària i Universitària de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46017', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario Dr. Peset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Availability of this study\'s data will be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}