End-stage Renal Disease (ESRD) Pilot Study

Phase 1

Completed

• Conditions: Renal Dialysis
• Interventions: Drug: BAY1213790; Drug: 0.9% sodium chloride solution

• Registration Number: NCT03787368
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-24
• Study First Submitted QC: 2018-12-24
• Study First Posted: 2018-12-26
• Study Start: 2019-01-31
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1 of BAY1213790	BAY1213790	Single intravenous infusion BAY1213790 (Dose 1)
Dose 2 of BAY1213790	BAY1213790	Single intravenous infusion BAY1213790 (Dose 2)
Placebo	0.9% sodium chloride solution	Single intravenous infusion placebo

Primary Outcome Measures

Name	Time	Method
Number of major and CRNM bleeding events	Approx. 4 weeks (After study drug or placebo administration)

Secondary Outcome Measures

Name	Time	Method
AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)	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)	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	Approx. 6 months (Before study drug or placebo administration to follow up)	FXI: Factor XI

Trial Locations

Locations (15)

Hospital Clínico Universitario de Santiago de Compostela; 🇪🇸 Santiago de Compostela, A Coruña, Spain

CHU de Charleroi Hôpital civil; 🇧🇪 Lodelinsart, Hainaut, Belgium

California Institute of Renal Research - Chula Vista; 🇺🇸 Chula Vista, California, United States

Research by Design, LLC; 🇺🇸 Chicago, Illinois, United States

Hospital Reina Sofía; 🇪🇸 Córdoba, Spain

CHLO - Hospital Santa Cruz; 🇵🇹 Carnaxide, Lisboa, Portugal

Pluribus Dialise - Cascais (DaVita); 🇵🇹 Cascais, Lisboa, Portugal

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Dr. Peset; 🇪🇸 Valencia, Spain

Nova Clinical Research, LLC; 🇺🇸 Bradenton, Florida, United States

Ciutat Sanitària i Universitària de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Renal and Transplant Associates of New England, PC; 🇺🇸 Springfield, Massachusetts, United States

CHMT - Hospital Rainha Santa Isabel; 🇵🇹 Torres Novas, Santarém, Portugal

UZ Brussel; 🇧🇪 Bruxelles - Brussel, Belgium

UZ Leuven Gasthuisberg; 🇧🇪 Leuven, Belgium