Trial Condition(s):
Renal Dialysis
End-stage renal disease (ESRD) pilot study
Bayer Identifier:
20046
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
Inclusion Criteria - Male and female patients between 18 and 80 years of age. - ESRD on hemodialysis (including hemodiafiltration) for at least 3 months - Life expectancy of > 6 months - Women of non-childbearing potential - High risk for clinically significant bleeding - Acute renal failure - Planned major surgery in the next 7 months from randomization - Concomitant use of oral anticoagulant therapy or antiplatelet therapy - Documented thrombotic event in the past 6 months
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Brussel BRUXELLES - BRUSSEL, Belgium, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Charleroi Hôpital civil Lodelinsart, Belgium, 6042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations California Institute of Renal Research - Chula Vista Chula Vista, United States, 91910 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Research by Design, LLC Chicago, United States, 60643 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention Barcelona, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Reina Sofía Córdoba, Spain, 14004 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Dr. Peset Valencia, Spain, 46017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Renal and Transplant Associates of New England, PC Springfield, United States, 01107 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nova Clinical Research | Brandenton, FL Brandenton, United States, 34209 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHLO - Hospital Santa Cruz Carnaxide, Portugal, 2795-53 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pluribus Dialise - Cascais (DaVita) Cascais, Portugal, 2750-663 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department Torres Novas, Portugal, 2350-754 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Number of major and CRNM bleeding eventsCRNM bleeding: Clinically Relevant Non-Major bleedingTimeframe: Approx. 4 weeks (Before study drug or placebo administration)
- Number of major and CRNM bleeding eventsTimeframe: 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) doseTimeframe: Approx. 5 months (Pre-dose to follow up)
- aPTT will be measured via the kaolin-trigger method (clotting assay)aPTT: activated Partial Thromboplastin TimeTimeframe: 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 XITimeframe: Approx. 6 months (Before study drug or placebo administration to follow up)
Additional Information
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