Clinical trial NCT03787368: End-stage Renal Disease (ESRD) Pilot 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Dialysis
Keywords: End-stage renal disease patients undergoing hemodialysis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-12-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of major and CRNM bleeding events
timeFrame: Approx. 4 weeks (Before study drug or placebo administration)
measure: Number of major and CRNM bleeding events
timeFrame: Approx. 4 weeks (After study drug or placebo administration)
Secondary outcomes:
measure: AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)
timeFrame: Approx. 5 months (Pre-dose to follow up)
measure: aPTT will be measured via the kaolin-trigger method (clotting assay)
timeFrame: Approx. 6 months (Before study drug or placebo administration to follow up)
measure: Factor XI activity will be assessed with an aPTT-based coagulation test using FXI
timeFrame: Approx. 6 months (Before study drug or placebo administration to follow up)
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: California Institute of Renal Research - Chula Vista
state: California
city: Bradenton
country: United States
facility: Nova Clinical Research, LLC
state: Florida
city: Chicago
country: United States
facility: Research by Design, LLC
state: Illinois
city: Springfield
country: United States
facility: Renal and Transplant Associates of New England, PC
state: Massachusetts
city: Lodelinsart
country: Belgium
facility: CHU de Charleroi Hôpital civil
state: Hainaut
city: Bruxelles - Brussel
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Carnaxide
country: Portugal
facility: CHLO - Hospital Santa Cruz
state: Lisboa
city: Cascais
country: Portugal
facility: Pluribus Dialise - Cascais (DaVita)
state: Lisboa
city: Torres Novas
country: Portugal
facility: CHMT - Hospital Rainha Santa Isabel
state: Santarém
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
city: L'Hospitalet de Llobregat
country: Spain
facility: Ciutat Sanitària i Universitària de Bellvitge
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
Study officials:
References: