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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 26, 2018
Last Update Posted : May 13, 2020
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 : July 30, 2021
Estimated Study Completion Date : July 30, 2021

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



Information from the National Library of Medicine

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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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Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03787368    
Other Study ID Numbers: 20046
2018-003109-24 ( EudraCT Number )
First Posted: December 26, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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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