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Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis

ConditionEnd-Stage Kidney Disease (ESKD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

This study will evaluate three Investigational Medicinal Products (IMPs) called REGN9933, REGN7508, and REGN9533.

The study is focused on participants with End-Stage Kidney Disease (ESKD) treated with hemodialysis and standard anticoagulant treatment, such as heparin, to reduce the risk of blood clots as they can lead to serious health problems or be life-threatening. Because participants with ESKD who have hemodialysis have a higher risk of bleeding, the IMPs could be a meaningful new therapeutic option.

The main aim of the study is to see what side effects may happen from taking REGN9933, REGN7508, or REGN9533.

The study is looking at several other research questions, including:

* How much IMP is in the blood at different times and * If the IMPs affect the ability of the blood to clot normally

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has ESKD and has regular adherence receiving HD 3 times per week as described in the protocol

Is receiving heparin (standard of care) anticoagulation, with no history of intolerability, during each dialysis session

Has adequate vascular access

Is clinically stable with no hospitalizations in the past 30 days prior to first screening visit as described in the protocol

Disqualifiers

Has history of major bleeding (International Society on Thrombosis and Haemostasis [ISTH]) criteria) within the past 3 months prior to the first screening visit as described in the protocol

Has known bleeding conditions (eg, Hemophilia A, B or C, von Willebrand's disease) hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy)

Current use of oral anticoagulants (eg, warfarin, Direct Oral Anti-Coagulant [DOACs]) or dual antiplatelet therapy for clinical indication

Heart failure as classified by New York Heart Association (NYHA) class III or IV

Trial design

Design model

Parallel

Treatments tested in this trial

  • REGN9933

    Drug

    Administered per the protocol

  • REGN7508

    Drug

    Administered per the protocol

  • REGN9533

    Drug

    Administered per the protocol

  • Heparin

    Drug

    Administered per the protocol

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: REGN9933Experimental treatment 2 interventions
Group B: REGN7508Experimental treatment 2 interventions
Group C: REGN9533Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Time frame
Up to approximately 78 days
2

Severity of TEAEs

Time frame
Up to approximately 78 days

Secondary outcomes

1

Concentrations of REGN9933

Time frame
Up to approximately 78 days
2

Concentrations of REGN7508

Time frame
Up to approximately 78 days
3

Concentrations of REGN9533

Time frame
Up to approximately 78 days
4

Change in activated Partial Thromboplastin Time (aPTT)

Time frame
From baseline up to approximately 78 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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