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End-stage Renal Disease (ESRD) Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03787368
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Renal Dialysis Drug: BAY1213790 Drug: 0.9% sodium chloride solution Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : January 31, 2019
Estimated Primary Completion Date : May 20, 2020
Estimated Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Number of major and CRNM bleeding events [ Time Frame: Approx. 4 weeks (Before study drug or placebo administration) ]
    CRNM bleeding: Clinically Relevant Non-Major bleeding

  2. Number of major and CRNM bleeding events [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Approx. 6 months (Before study drug or placebo administration to follow up) ]
    FXI: Factor XI



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787368


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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United States, California
California Institute of Renal Research Recruiting
Chula Vista, California, United States, 91910
United States, Connecticut
Nephrology and Hypertension Associates Withdrawn
Middlebury, Connecticut, United States, 06762
United States, Florida
Nova Clinical Research Recruiting
Bradenton, Florida, United States, 34209
Florida Kidney Center FMC # 1095 Not yet recruiting
Lauderhill, Florida, United States, 33319
United States, Illinois
Research by Design, LLC Recruiting
Chicago, Illinois, United States, 60643
United States, Massachusetts
Renal and Transplant Associates of New England, PC Not yet recruiting
Springfield, Massachusetts, United States, 01107
United States, Minnesota
DaVita Clinical Research Withdrawn
Minneapolis, Minnesota, United States, 55404
United States, Texas
Dallas Nephrology Associates Not yet recruiting
Dallas, Texas, United States, 75235
El Paso Kidney Specialists, PA Withdrawn
El Paso, Texas, United States, 79902
DaVita Med Center Dialysis Withdrawn
Houston, Texas, United States, 77004
San Antonio Kidney Disease Center Withdrawn
San Antonio, Texas, United States, 78229
Belgium
CHU de Charleroi Hôpital civil Recruiting
Lodelinsart, Hainaut, Belgium, 6042
UZ Brussel Recruiting
Bruxelles - Brussel, Belgium, 1090
CU Saint-Luc/UZ St-Luc Not yet recruiting
Bruxelles - Brussel, Belgium, 1200
UZ Leuven Gasthuisberg Recruiting
Leuven, Belgium, 3000
Portugal
Eurodial - Centro Nefro. e Hemodialise Leiria - Ext.Obidos Withdrawn
Gaeiras - Obidos, Leiria, Portugal, 2510-702
Centro Hospitalar de Lisboa Ocidental, EPE - H.Santa Cruz Not yet recruiting
Carnaxide, Lisboa, Portugal, 2795-53
Pluribus Dialise - Cascais, S.A. - Grupo DaVita Not yet recruiting
Cascais, Lisboa, Portugal, 2750-663
NephroCare APDP Withdrawn
Lisboa, Portugal, 1250-191
Centro Hospitalar do Médio Tejo Not yet recruiting
Torres Novas, Portugal
Spain
Hospital Clínico Universitario de Santiago de Compostela Not yet recruiting
Santiago de Compostela, A Coruña, Spain, 15706
Ciutat Sanitària i Universitària de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Reina Sofía Recruiting
Córdoba, Spain, 14004
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Hospital Universitario Dr. Peset Recruiting
Valencia, Spain, 46017
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03787368     History of Changes
Other Study ID Numbers: 20046
2018-003109-24 ( EudraCT Number )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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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:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency