End-stage Renal Disease (ESRD) Pilot Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03787368

Enrollment

Registered

2018-12-26

Start date

2019-01-31

Completion date

2021-09-15

Last updated

2022-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Dialysis

Keywords

End-stage renal disease patients undergoing hemodialysis

Brief summary

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.

Interventions

DRUGBAY1213790

Single intravenous infusion of BAY1213790 (Two different doses)

DRUG0.9% sodium chloride solution

Single intravenous infusion of Placebo (0.9% sodium chloride solution)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Number of major and CRNM bleeding events	Approx. 4 weeks (Before study drug or placebo administration)	CRNM bleeding: Clinically Relevant Non-Major bleeding

Secondary

Measure	Time frame	Description
AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)	Approx. 5 months (Pre-dose to follow up)	AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose
aPTT will be measured via the kaolin-trigger method (clotting assay)	Approx. 6 months (Before study drug or placebo administration to follow up)	aPTT: activated Partial Thromboplastin Time
Factor XI activity will be assessed with an aPTT-based coagulation test using FXI	Approx. 6 months (Before study drug or placebo administration to follow up)	FXI: Factor XI

Countries

Belgium, Portugal, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026