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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003109-24 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 of BAY1213790 | Experimental | Single intravenous infusion BAY1213790 (Dose 1) |
|
| Dose 2 of BAY1213790 | Experimental | Single intravenous infusion BAY1213790 (Dose 2) |
|
| Placebo | Placebo Comparator | Single intravenous infusion placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1213790 | Drug | Single intravenous infusion of BAY1213790 (Two different doses) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of major and CRNM bleeding events | CRNM bleeding: Clinically Relevant Non-Major bleeding | Approx. 4 weeks (Before study drug or placebo administration) |
| Number of major and CRNM bleeding events | Approx. 4 weeks (After study drug or placebo administration) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) dose | Approx. 5 months (Pre-dose to follow up) |
| aPTT will be measured via the kaolin-trigger method (clotting assay) |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Institute of Renal Research - Chula Vista | Chula Vista | California | 91910 | United States | ||
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.
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| ID | Term |
|---|---|
| C000657125 | osocimab |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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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.
| 0.9% sodium chloride solution | Drug | Single intravenous infusion of Placebo (0.9% sodium chloride solution) |
|
aPTT: activated Partial Thromboplastin Time |
| 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 FXI | FXI: Factor XI | Approx. 6 months (Before study drug or placebo administration to follow up) |
| Nova Clinical Research, LLC |
| Bradenton |
| Florida |
| 34209 |
| United States |
| Research by Design, LLC | Chicago | Illinois | 60643 | United States |
| Renal and Transplant Associates of New England, PC | Springfield | Massachusetts | 01107 | United States |
| CHU de Charleroi Hôpital civil | Lodelinsart | Hainaut | 6042 | Belgium |
| UZ Brussel | Bruxelles - Brussel | 1090 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHLO - Hospital Santa Cruz | Carnaxide | Lisbon District | 2795-53 | Portugal |
| Pluribus Dialise - Cascais (DaVita) | Cascais | Lisbon District | 2750-663 | Portugal |
| CHMT - Hospital Rainha Santa Isabel | Torres Novas | Santarém District | 2350-754 | Portugal |
| Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | A Coruña | 15706 | Spain |
| Ciutat Sanitària i Universitària de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitario Dr. Peset | Valencia | 46017 | Spain |
| D017670 |
| Sodium Compounds |