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. Patients with kidney disease undergoing regular dialysis are at high risk for…
ID
Source
Brief title
Condition
- Nephropathies
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Outcome Measures:
• 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 ]
Secondary outcome
Secondary Outcome Measures:
• 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.
Background summary
Study to investigate the safety of a drug called Osocimab at low and high doses
in adult patients with kidney failure requiring regular hemodialysis.
Study objective
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. 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 and blood vessels diseases
without increasing the risk of bleeding. 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.
Study design
A randomized, double-blind, parallel group, placebo-controlled, multi-center
study.
Intervention
This study compares 2 different doses of Osocimab with 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 starting at visit 8 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 starting at visit 8 until the end of the extension
treatment period.
Experimental: Placebo high dose
Placebo will be administered subcutaneously in the same manner as Osocimab.
Study burden and risks
Patient's burden consists of the extra time investment during study
participation. The patient will not be asked to bring extra visits to the
hospital: all study visits are combined with the standard dialysis visits.
However, the patient will spend a maximum of 30 minutes of extra time during
the combined study visits if this visit concerns an IMP administration (within
a period of min. 11 to max. 23 months). The patient will undergo physical
examination 3x till 6x (resp. in 11 and 23 months study duration). There will
be 17x till 33x heartbeat and blood pressure measurement (at every visit,
dependent on visit duration) and 7x till 11x ECG measurement (dependent on
study duration). Once a month (but more frequently at the beginning of the
study), a blood sample will be taken via the hemodialysis line or catheter. The
patient could experience a certain extent of burden during these actions and
measurements.
The treatment consists of max. 18x a subcutaneous injection. A possible side
effect of this can be hypersensitivity for the injection or allergic reactions
to Osocimab. Because of this investigational product's nature, bleeding can be
a possible side effect after Osocimab administration. In addition, the
following side effects can be expected: low platelet count, development of
antibodies that hinder Osocimab's effect.
When the burden and risks are adversely experienced by the patient, he or she
is allowed to stop the study participation without any explicit reason and
without any consequences for the medical care.
Energieweg 1
Mijdrecht 3641RT
NL
Energieweg 1
Mijdrecht 3641RT
NL
Listed location countries
Age
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 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003957-27-NL |
| CCMO | NL73935.100.20 |