ClinicaliQ Trial Snapshot
- A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) — Recruiting • Phase III • NCT06935357.
- In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of….
- Sponsor: Biogen.
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What This Trial Is Studying
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is: • How much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will learn about the effect…
Eligibility Snapshot
- Key Inclusion Criteria: * Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, biopsy confirmation of IgAN diagnosis must be done within the past 24 months prior to signing the ICF. * An eGFR ≥ 30 mL/min/1.73m^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and < 30 mL/min/1.73m^2 is acceptable for the cohorts 3 and 4. * Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine collection. * Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening, or intolerant of ACEI or ARB. If intolerant, this must be discussed with the Medical Monitor prior to randomization. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is), endothelin receptor antagonists (ERAs) approved for the treatment of IgAN, dual endothelin angiotensin receptor antagonist (DEARAs) approved for the treatment of IgAN, and/or mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable…
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