check_circleStudy Completed
Renal Dialysis
Bayer Identifier:
20046
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
End-stage renal disease (ESRD) pilot study
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - 80 YearsTrial summary
Enrollment Goal
61Trial Dates
January 2019 - September 2021Phase
Phase 1Could I Receive a placebo
NoProducts
Osocimab (BAY1213790)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | UZ Brussel | BRUXELLES - BRUSSEL, 1090, Belgium |
Completed | CHU de Charleroi Hôpital civil | Lodelinsart, 6042, Belgium |
Withdrawn | Florida Kidney Center FMC # 1095 | Lauderhill, 33319, United States |
Completed | California Institute of Renal Research - Chula Vista | Chula Vista, 91910, United States |
Completed | Research by Design, LLC | Chicago, 60643, United States |
Withdrawn | San Antonio Kidney Disease Center | San Antonio, 78229, United States |
Withdrawn | Nephrology and Hypertension Associates, P.C. | Middlebury, 06762, United States |
Withdrawn | DaVita Clinical Research / Minneapolis, MN | Minneapolis, 55404, United States |
Withdrawn | El Paso Kidney Specialists, PA | El Paso, 79902-4821, United States |
Completed | Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention | Barcelona, 08907, Spain |
Completed | Hospital Clínico Universitario de Valencia | Valencia, 46010, Spain |
Completed | Hospital Reina Sofía | Córdoba, 14004, Spain |
Withdrawn | DaVita Med Center Dialysis | Houston, 77004-7515, United States |
Completed | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela, 15706, Spain |
Completed | Hospital Universitario Dr. Peset | Valencia, 46017, Spain |
Completed | Renal and Transplant Associates of New England, PC | Springfield, 01107, United States |
Completed | Nova Clinical Research | Brandenton, FL | Brandenton, 34209, United States |
Withdrawn | Dallas Nephrology Associates | Dallas, 75235, United States |
Withdrawn | Eurodial Obidos (DaVita) | Gaeiras - Obidos, 2510-702, Portugal |
Completed | CHLO - Hospital Santa Cruz | Carnaxide, 2795-53, Portugal |
Withdrawn | NephroCare APDP | Lisboa, 1250-191, Portugal |
Completed | Pluribus Dialise - Cascais (DaVita) | Cascais, 2750-663, Portugal |
Completed | Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department | Torres Novas, 2350-754, Portugal |
Primary Outcome
- Number of major and CRNM bleeding eventsCRNM bleeding: Clinically Relevant Non-Major bleedingdate_rangeTime Frame:Approx. 4 weeks (Before study drug or placebo administration)
- Number of major and CRNM bleeding eventsdate_rangeTime Frame:Approx. 4 weeks (After study drug or placebo administration)
Secondary Outcome
- AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dosedate_rangeTime Frame:Approx. 5 months (Pre-dose to follow up)
- aPTT will be measured via the kaolin-trigger method (clotting assay)aPTT: activated Partial Thromboplastin Timedate_rangeTime Frame:Approx. 6 months (Before study drug or placebo administration to follow up)
- Factor XI activity will be assessed with an aPTT-based coagulation test using FXIFXI: Factor XIdate_rangeTime Frame:Approx. 6 months (Before study drug or placebo administration to follow up)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3