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End-stage Renal Disease (ESRD) Pilot Study

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT03787368
Collaborator
(none)
55
Enrollment
15
Locations
3
Arms
31.5
Actual Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 31, 2019
Actual Primary Completion Date :
Sep 15, 2021
Actual Study Completion Date :
Sep 15, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Number of major and CRNM bleeding events [Approx. 4 weeks (Before study drug or placebo administration)]

    CRNM bleeding: Clinically Relevant Non-Major bleeding

  2. Number of major and CRNM bleeding events [Approx. 4 weeks (After study drug or placebo administration)]

Secondary Outcome Measures

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 California Institute of Renal Research - Chula Vista Chula Vista California United States 91910
2 Nova Clinical Research, LLC Bradenton Florida United States 34209
3 Research by Design, LLC Chicago Illinois United States 60643
4 Renal and Transplant Associates of New England, PC Springfield Massachusetts United States 01107
5 CHU de Charleroi Hôpital civil Lodelinsart Hainaut Belgium 6042
6 UZ Brussel Bruxelles - Brussel Belgium 1090
7 UZ Leuven Gasthuisberg Leuven Belgium 3000
8 CHLO - Hospital Santa Cruz Carnaxide Lisboa Portugal 2795-53
9 Pluribus Dialise - Cascais (DaVita) Cascais Lisboa Portugal 2750-663
10 CHMT - Hospital Rainha Santa Isabel Torres Novas Santarém Portugal 2350-754
11 Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela A Coruña Spain 15706
12 Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat Barcelona Spain 08907
13 Hospital Reina Sofía Córdoba Spain 14004
14 Hospital Clínico Universitario de Valencia Valencia Spain 46010
15 Hospital Universitario Dr. Peset Valencia Spain 46017

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT03787368
Other Study ID Numbers:
  • 20046
  • 2018-003109-24
First Posted:
Dec 26, 2018
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bayer
End-stage renal disease patients undergoing hemodialysis
Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic

Study Results

No Results Posted as of Mar 16, 2022