End-stage Renal Disease (ESRD) Pilot Study
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.
Full Title of 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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: September 15, 2021
Interventions
- Drug: BAY1213790
- Single intravenous infusion of BAY1213790 (Two different doses)
- Drug: 0.9% sodium chloride solution
- Single intravenous infusion of Placebo (0.9% sodium chloride solution)
Arms, Groups and Cohorts
- Experimental: Dose 1 of BAY1213790
- Single intravenous infusion BAY1213790 (Dose 1)
- Experimental: Dose 2 of BAY1213790
- Single intravenous infusion BAY1213790 (Dose 2)
- Placebo Comparator: Placebo
- Single intravenous infusion placebo
Clinical Trial Outcome Measures
Primary Measures
- Number of major and CRNM bleeding events
- Time Frame: Approx. 4 weeks (Before study drug or placebo administration)
- CRNM bleeding: Clinically Relevant Non-Major bleeding
- Number of major and CRNM bleeding events
- Time Frame: Approx. 4 weeks (After study drug or placebo administration)
Secondary Measures
- AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)
- Time Frame: 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)
- Time Frame: 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
- Time Frame: Approx. 6 months (Before study drug or placebo administration to follow up)
- FXI: Factor XI
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Bayer
- Provider of Information About this Clinical Study
- Sponsor
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