Status:
COMPLETED
Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis
Lead Sponsor:
Bayer
Conditions:
End-stage Renal Disease
Prevention of Thromboembolic Events
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
704 Patients enrolled
Trial Details
Trial ID
NCT04523220
Start Date
August 28 2020
End Date
May 30 2022
Last Update
July 21 2023
Active Locations (151)
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1
North America Research Institute - Azusa
Azusa, California, United States, 91702
2
Fresenius Kidney Care - Brawley
Brawley, California, United States, 92227
3
DaVita South Valley Dialysis
Encino, California, United States, 91316
4
Fresenius Kidney Care - La Mesa
La Mesa, California, United States, 91942