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)
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| ClinicalTrials.gov Identifier: NCT04523220 |
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Recruitment Status :
Completed
First Posted : August 21, 2020
Last Update Posted : July 14, 2022
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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 |
|---|---|---|
| End-stage Renal Disease Prevention of Thromboembolic Events Hemodialysis Hemodiafiltration | Drug: BAY1213790 (Osocimab) Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 686 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 |
| Actual Primary Completion Date : | December 28, 2021 |
| Actual Study Completion Date : | May 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: BAY1213790 (Osocimab)
Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses. |
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Placebo Comparator: Placebo low dose
Placebo will be administered subcutaneously in the same manner as Osocimab.
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Drug: Placebo
Subcutaneous administration in the same manner as Osocimab. |
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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.
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Drug: BAY1213790 (Osocimab)
Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses. |
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Experimental: Placebo high dose
Placebo will be administered subcutaneously in the same manner as Osocimab.
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Drug: Placebo
Subcutaneous administration in the same manner as Osocimab. |
- 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 ]
- 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 ]
- Activated partial thromboplastin time (aPTT) at trough levels [ Time Frame: At baseline and after 6 months ]aPTT will be measured
- Factor XIa (FXIa) activity at trough levels [ Time Frame: At baseline and after 6 months ]Factor XI activity will be assessed
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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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: | July 14, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | There are no current plans to share data. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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End-stage renal disease (ESRD) Hemodialysis |
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Kidney Diseases Kidney Failure, Chronic Thromboembolism Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases |
Renal Insufficiency, Chronic Renal Insufficiency Chronic Disease Disease Attributes Pathologic Processes Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |