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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04523220




Registration number
NCT04523220
Ethics application status
Date submitted
20/08/2020
Date registered
21/08/2020
Date last updated
21/07/2023

Titles & IDs
Public title
Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis
Scientific 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
Secondary ID [1] 0 0
2019-003957-27
Secondary ID [2] 0 0
20115
Universal Trial Number (UTN)
Trial acronym
CONVERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-stage Renal Disease 0 0
Prevention of Thromboembolic Events 0 0
Hemodialysis 0 0
Hemodiafiltration 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAY1213790 (Osocimab)
Treatment: Drugs - Placebo

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.

Placebo Comparator: Placebo low dose - Placebo will be administered subcutaneously 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.

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


Treatment: Drugs: BAY1213790 (Osocimab)
Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.

Treatment: Drugs: Placebo
Subcutaneous administration in the same manner as Osocimab.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative Incidence Risk of the First Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) Events as Assessed by Blinded Central Independent Adjudication Committee (CIAC)
Timepoint [1] 0 0
From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months
Primary outcome [2] 0 0
Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From the first dose of study intervention up until 30 days after last study intervention in the main treatment period, up to 6 months
Secondary outcome [1] 0 0
Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.
Timepoint [1] 0 0
At 6 months (Visit 19 / Day 30 of the 6th month)
Secondary outcome [2] 0 0
Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline
Timepoint [2] 0 0
At 6 months (Visit 19 / Day 30 of the 6th month)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Recent (<6 months before screening) clinically significant bleeding

- Hemoglobin (Hb) < 9.0 g/dL at screening

- Platelet count < 100 x 10^9/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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/05/2022
Sample size
Target
Accrual to date
Final
704
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Eastern Health Integrated Renal Service - Box Hill
Recruitment hospital [4] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
2305 - New Lambton Heights
Recruitment outside Australia
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United States of America
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California
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Connecticut
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Utah
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Virginia
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Austria
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Kärnten
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Istanbul
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Dnipro
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Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
In this study researchers want to learn about the safety of drug Osocimab at lower-dose and
higher-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 lower-dose
or higher-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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04523220
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Phone 0 0
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Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04523220