End-stage Renal Disease (ESRD) Pilot 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

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.

Study Overview

• Status: Completed
• Conditions: Renal Dialysis
• Intervention / Treatment: Drug: BAY1213790; Drug: 0.9% sodium chloride solution

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles - Brussel, Belgium, 1090
    • UZ Brussel
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
  • Hainaut
    • Lodelinsart, Hainaut, Belgium, 6042
      • CHU de Charleroi Hôpital civil
• Portugal
  • Lisboa
    • Carnaxide, Lisboa, Portugal, 2795-53
      • CHLO - Hospital Santa Cruz
    • Cascais, Lisboa, Portugal, 2750-663
      • Pluribus Dialise - Cascais (DaVita)
  • Santarém
    • Torres Novas, Santarém, Portugal, 2350-754
      • CHMT - Hospital Rainha Santa Isabel
• Spain
  • Córdoba, Spain, 14004
    • Hospital Reina Sofia
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Hospital Clinico Universitario de Santiago de Compostela
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Ciutat Sanitaria i Universitaria de Bellvitge
• United States
  • California
    • Chula Vista, California, United States, 91910
      • California Institute of Renal Research - Chula Vista
  • Florida
    • Bradenton, Florida, United States, 34209
      • Nova Clinical Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research by Design, LLC
  • Massachusetts
    • Springfield, Massachusetts, United States, 01107
      • Renal and Transplant Associates of New England, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

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)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: December 24, 2018
• First Submitted That Met QC Criteria: December 24, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: End-stage renal disease patients undergoing hemodialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 20046; 2018-003109-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No