A Phase 1 interventional study of REGN9933 and REGN7508 in End-Stage Kidney Disease (ESKD), sponsored by Regeneron Pharmaceuticals. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment
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:
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 36 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: REGN9933 · Drug: Heparin
Drug: REGN7508 · Drug: Heparin
Drug: REGN9533 · Drug: Heparin
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 78 days
Severity of TEAEs
Time frame: Up to approximately 78 days
Concentrations of REGN9933
Time frame: Up to approximately 78 days
Concentrations of REGN7508
Time frame: Up to approximately 78 days
Concentrations of REGN9533
Time frame: Up to approximately 78 days
Change in activated Partial Thromboplastin Time (aPTT)
Time frame: From baseline up to approximately 78 days
Change in Prothrombin Time (PT)
Time frame: From baseline up to approximately 78 days
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Apr 2027, 6 months after the start.
Of 46 industry-sponsored phase 1 interventional studies under Kidney Failure, Chronic, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's planned 6 months is below that.
Counting every sponsor, half of 67 studies reached it within 12 months; a quarter within 5 and three quarters within 27.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 6, 2026: primary completion Mar 2027 → Apr 2027 and completion Mar 2027 → Apr 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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