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Completed

NCT Number: NCT04523220

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

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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodiafiltration Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prevention of Thromboembolic Events Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sydney Adventist Hospital, Wahroonga, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY1213790 (Osocimab)

Drug

Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.

Placebo

Drug

Subcutaneous administration in the same manner as Osocimab.

Primary outcomes

  1. 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)

    Time frame: From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months

    Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table.

    Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis.

    Descriptive time to composite of treatment emergent major and CRNMB events [in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.

  2. Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From the first dose of study intervention up until 30 days after last study intervention in the main treatment period, up to 6 months

    Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table.

    Descriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis.

    An AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.

Secondary outcomes

  1. Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.

    Time frame: At 6 months (Visit 19 / Day 30 of the 6th month)

    The aPTT at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation).

    aPTT was measured via the kaolin-trigger method (clotting assay).

  2. Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline

    Time frame: At 6 months (Visit 19 / Day 30 of the 6th month)

    The Factor XI (FXI) activity at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation).

    Factor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: CONVERT

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 21, 2020
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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