End-stage Renal Disease (ESRD) Pilot Study

Renal Dialysis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787368
• Other study ID #: 20046
• Secondary ID: 2018-003109-24
• Status: Completed
• Phase: Phase 1
• Start date: January 31, 2019
• Est. completion date: September 15, 2021

Study information

• Verified date: March 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Dialysis

Intervention

Drug:
• BAY1213790
Single intravenous infusion of BAY1213790 (Two different doses)
• 0.9% sodium chloride solution
Single intravenous infusion of Placebo (0.9% sodium chloride solution)

Locations

Country	Name	City	State
Belgium	UZ Brussel	Bruxelles - Brussel
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	CHU de Charleroi Hôpital civil	Lodelinsart	Hainaut
Portugal	CHLO - Hospital Santa Cruz	Carnaxide	Lisboa
Portugal	Pluribus Dialise - Cascais (DaVita)	Cascais	Lisboa
Portugal	CHMT - Hospital Rainha Santa Isabel	Torres Novas	Santarém
Spain	Hospital Reina Sofía	Córdoba
Spain	Ciutat Sanitària i Universitària de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario Dr. Peset	Valencia
United States	Nova Clinical Research, LLC	Bradenton	Florida
United States	Research by Design, LLC	Chicago	Illinois
United States	California Institute of Renal Research - Chula Vista	Chula Vista	California
United States	Renal and Transplant Associates of New England, PC	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of major and CRNM bleeding events	CRNM bleeding: Clinically Relevant Non-Major bleeding	Approx. 4 weeks (Before study drug or placebo administration)
Primary	Number of major and CRNM bleeding events		Approx. 4 weeks (After study drug or placebo administration)
Secondary	AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-8) >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)
Secondary	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)
Secondary	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)