End-stage Renal Disease (ESRD) Pilot Study

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Renal Dialysis

Intervention / Treatment
-----------------
* Drug: BAY1213790
* Drug: 0.9% sodium chloride solution


Participation Criteria
=================
Eligibility 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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 of BAY1213790<br>Single intravenous infusion BAY1213790 (Dose 1) | Drug: BAY1213790<br>* Single intravenous infusion of BAY1213790 (Two different doses)<br>|
| Experimental: Dose 2 of BAY1213790<br>Single intravenous infusion BAY1213790 (Dose 2) | Drug: BAY1213790<br>* Single intravenous infusion of BAY1213790 (Two different doses)<br>|
| Placebo Comparator: Placebo<br>Single intravenous infusion placebo | Drug: 0.9% sodium chloride solution<br>* Single intravenous infusion of Placebo (0.9% sodium chloride solution)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Approx. 5 months (Pre-dose to follow up) | 
| aPTT will be measured via the kaolin-trigger method (clotting assay) | aPTT: activated Partial Thromboplastin Time | 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 | Approx. 6 months (Before study drug or placebo administration to follow up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End-stage renal disease patients undergoing hemodialysis