End-stage Renal Disease (ESRD) Pilot Study

Bayer55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Renal Dialysis

Interventions

BAY1213790DRUG

Single intravenous infusion of BAY1213790 (Two different doses)

0.9% sodium chloride solutionDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (15)

California Institute of Renal Research - Chula Vista

Chula Vista, California, United States

Nova Clinical Research, LLC

Bradenton, Florida, United States

Outcomes

Primary Outcomes

Number of major and CRNM bleeding events

CRNM bleeding: Clinically Relevant Non-Major bleeding

Time frame: Approx. 4 weeks (Before study drug or placebo administration)

Number of major and CRNM bleeding events

Time frame: Approx. 4 weeks (After study drug or placebo administration)

Secondary Outcomes

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

Time 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

Time 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

Time frame: Approx. 6 months (Before study drug or placebo administration to follow up)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.