check_circleStudy Completed

Renal Dialysis

Bayer Identifier:

20046

ClinicalTrials.gov Identifier:

NCT03787368

EudraCT Number:

2018-003109-24

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

All

Age

18 - 80 Years
  • - 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
61
Trial Dates
January 2019 - September 2021
Phase
Phase 1
Could I Receive a placebo
No
Products
Osocimab (BAY1213790)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
UZ BrusselBRUXELLES - BRUSSEL, 1090, Belgium
Completed
CHU de Charleroi Hôpital civilLodelinsart, 6042, Belgium
Withdrawn
Florida Kidney Center FMC # 1095Lauderhill, 33319, United States
Completed
California Institute of Renal Research - Chula VistaChula Vista, 91910, United States
Completed
Research by Design, LLCChicago, 60643, United States
Withdrawn
San Antonio Kidney Disease CenterSan Antonio, 78229, United States
Withdrawn
Nephrology and Hypertension Associates, P.C.Middlebury, 06762, United States
Withdrawn
DaVita Clinical Research / Minneapolis, MNMinneapolis, 55404, United States
Withdrawn
El Paso Kidney Specialists, PAEl Paso, 79902-4821, United States
Completed
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke PreventionBarcelona, 08907, Spain
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Completed
Hospital Reina SofíaCórdoba, 14004, Spain
Withdrawn
DaVita Med Center DialysisHouston, 77004-7515, United States
Completed
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Completed
Hospital Universitario Dr. PesetValencia, 46017, Spain
Completed
Renal and Transplant Associates of New England, PCSpringfield, 01107, United States
Completed
Nova Clinical Research | Brandenton, FLBrandenton, 34209, United States
Withdrawn
Dallas Nephrology AssociatesDallas, 75235, United States
Withdrawn
Eurodial Obidos (DaVita)Gaeiras - Obidos, 2510-702, Portugal
Completed
CHLO - Hospital Santa CruzCarnaxide, 2795-53, Portugal
Withdrawn
NephroCare APDPLisboa, 1250-191, Portugal
Completed
Pluribus Dialise - Cascais (DaVita)Cascais, 2750-663, Portugal
Completed
Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology DepartmentTorres Novas, 2350-754, Portugal

Primary Outcome

  • Number of major and CRNM bleeding events
    CRNM bleeding: Clinically Relevant Non-Major bleeding
    date_rangeTime Frame:
    Approx. 4 weeks (Before study drug or placebo administration)
  • Number of major and CRNM bleeding events
    date_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) dose
    date_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 Time
    date_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 FXI
    FXI: Factor XI
    date_rangeTime Frame:
    Approx. 6 months (Before study drug or placebo administration to follow up)

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

Additional Information

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