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End-stage Renal Disease (ESRD) Pilot Study

Primary Purpose

Renal Dialysis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BAY1213790
0.9% sodium chloride solution
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Dialysis focused on measuring End-stage renal disease patients undergoing hemodialysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Institute of Renal Research - Chula Vista
  • Nova Clinical Research, LLC
  • Research by Design, LLC
  • Renal and Transplant Associates of New England, PC
  • CHU de Charleroi Hôpital civil
  • UZ Brussel
  • UZ Leuven Gasthuisberg
  • CHLO - Hospital Santa Cruz
  • Pluribus Dialise - Cascais (DaVita)
  • CHMT - Hospital Rainha Santa Isabel
  • Hospital Clínico Universitario de Santiago de Compostela
  • Ciutat Sanitària i Universitària de Bellvitge
  • Hospital Reina Sofía
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitario Dr. Peset

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dose 1 of BAY1213790

Dose 2 of BAY1213790

Placebo

Arm Description

Single intravenous infusion BAY1213790 (Dose 1)

Single intravenous infusion BAY1213790 (Dose 2)

Single intravenous infusion placebo

Outcomes

Primary Outcome Measures

Number of major and CRNM bleeding events
CRNM bleeding: Clinically Relevant Non-Major bleeding
Number of major and CRNM bleeding events

Secondary Outcome Measures

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
aPTT will be measured via the kaolin-trigger method (clotting assay)
aPTT: activated Partial Thromboplastin Time
Factor XI activity will be assessed with an aPTT-based coagulation test using FXI
FXI: Factor XI

Full Information

First Posted
December 24, 2018
Last Updated
March 15, 2022
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03787368
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Dialysis
Keywords
End-stage renal disease patients undergoing hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Patients, investigators, and all other site staff will remain blinded for the administered BAY1213790 or placebo, with the exception of the unblinded pharmacist or specifically dedicated site personnel.The sponsor will be not be blinded. Bioanalysis of plasma concentrations and PD parameters, as well as the evaluation of results will be performed in a non-blinded fashion.
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1 of BAY1213790
Arm Type
Experimental
Arm Description
Single intravenous infusion BAY1213790 (Dose 1)
Arm Title
Dose 2 of BAY1213790
Arm Type
Experimental
Arm Description
Single intravenous infusion BAY1213790 (Dose 2)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single intravenous infusion placebo
Intervention Type
Drug
Intervention Name(s)
BAY1213790
Intervention Description
Single intravenous infusion of BAY1213790 (Two different doses)
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride solution
Intervention Description
Single intravenous infusion of Placebo (0.9% sodium chloride solution)
Primary Outcome Measure Information:
Title
Number of major and CRNM bleeding events
Description
CRNM bleeding: Clinically Relevant Non-Major bleeding
Time Frame
Approx. 4 weeks (Before study drug or placebo administration)
Title
Number of major and CRNM bleeding events
Time Frame
Approx. 4 weeks (After study drug or placebo administration)
Secondary Outcome Measure Information:
Title
AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)
Description
AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose
Time Frame
Approx. 5 months (Pre-dose to follow up)
Title
aPTT will be measured via the kaolin-trigger method (clotting assay)
Description
aPTT: activated Partial Thromboplastin Time
Time Frame
Approx. 6 months (Before study drug or placebo administration to follow up)
Title
Factor XI activity will be assessed with an aPTT-based coagulation test using FXI
Description
FXI: Factor XI
Time Frame
Approx. 6 months (Before study drug or placebo administration to follow up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
California Institute of Renal Research - Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Nova Clinical Research, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Research by Design, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
Facility Name
Renal and Transplant Associates of New England, PC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
CHU de Charleroi Hôpital civil
City
Lodelinsart
State/Province
Hainaut
ZIP/Postal Code
6042
Country
Belgium
Facility Name
UZ Brussel
City
Bruxelles - Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHLO - Hospital Santa Cruz
City
Carnaxide
State/Province
Lisboa
ZIP/Postal Code
2795-53
Country
Portugal
Facility Name
Pluribus Dialise - Cascais (DaVita)
City
Cascais
State/Province
Lisboa
ZIP/Postal Code
2750-663
Country
Portugal
Facility Name
CHMT - Hospital Rainha Santa Isabel
City
Torres Novas
State/Province
Santarém
ZIP/Postal Code
2350-754
Country
Portugal
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Ciutat Sanitària i Universitària de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

End-stage Renal Disease (ESRD) Pilot Study

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