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Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis (CONVERT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04523220
Recruitment Status : Active, not recruiting
First Posted : August 21, 2020
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

In this study researchers want to learn about the safety of drug Osocimab at low and high doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug.

Participants in this study will receive monthly injection of either Osocimab at a low or high dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.


Condition or disease Intervention/treatment Phase
Prevention of Thromboembolic Events in ESRD Patients on Hemodialysis Who Are at Risk for Thromboembolic Events Drug: BAY1213790 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study to Assess the Safety and Tolerability of Monthly Subcutaneous Administrations of a Low and High Dose Cohort of Osocimab to ESRD Patients on Regular Hemodialysis
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : January 2, 2022
Estimated Study Completion Date : June 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: BAY1213790 low dose
Participants will receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg until the end of the extension treatment period.
Drug: BAY1213790
Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.
Other Name: Osocimab; anti-Factor XIa antibody

Placebo Comparator: Placebo low dose
Placebo will be administered subcutaneously in the same manner as Osocimab.
Drug: Placebo
Subcutaneous administration in the same manner as Osocimab.

Experimental: BAY1213790 high dose
Participants will receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg until the end of the extension treatment period.
Drug: BAY1213790
Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.
Other Name: Osocimab; anti-Factor XIa antibody

Experimental: Placebo high dose
Placebo will be administered subcutaneously in the same manner as Osocimab.
Drug: Placebo
Subcutaneous administration in the same manner as Osocimab.




Primary Outcome Measures :
  1. Composite of major and clinically-relevant non-major bleeding events as assessed by blinded Central Independent Adjudication Committee (CIAC) [ Time Frame: From the first dose at month 1 and up to 6 months ]
  2. Composite of moderate and severe adverse ( AEs) and serious adverse events (SAEs) [ Time Frame: From the first dose at month 1 and up to 6 months ]

Secondary Outcome Measures :
  1. Activated partial thromboplastin time (aPTT) at trough levels [ Time Frame: At baseline and after 6 months ]
    aPTT will be measured

  2. Factor XIa (FXIa) activity at trough levels [ Time Frame: At baseline and after 6 months ]
    Factor XI activity will be assessed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be at least 18 years of age
  • Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for ≥3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator
  • Body weight of at least 50 kg
  • Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

  • Recent (<6 months before screening) clinically significant bleeding
  • Hemoglobin (Hb) < 9.0 g/dL at screening
  • Platelet count < 100 x 109/L
  • aPTT or PT > ULN (upper limit of normal)
  • Hepatic disease associated with ALT > 3x ULN, or total bilirubin >2x ULN with direct bilirubin > 20% of the total
  • Sustained uncontrolled hypertension (diastolic blood pressure ≥100 mmHg and/or systolic blood pressure ≥ 180 mmHg)
  • Known intracranial neoplasm, arteriovenous malformation or aneurysm
  • Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C
  • Recent (<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke or VTE (except dialysis access thrombosis)
  • Recent (<3 months before screening) major surgery or scheduled major surgery during study participation
  • Scheduled living donor renal transplant during study participation
  • Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher
  • Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day
  • Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure

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): NCT04523220


Locations
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Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04523220    
Other Study ID Numbers: 20115
2019-003957-27 ( EudraCT Number )
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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 (ESRD)
Hemodialysis
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases