Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)


About this study

The purpose of this study is to evaluate effects on proteinuria and glomerular filtration rate of sibeprenlimab 400 mg subcutaneously (s.c.) Q 4 weeks in adults with IgAN who are receiving maximally tolerated standard-of-care therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Male and female patients ≥ 18 years of age .

- Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m^2 must have had
a kidney biopsy performed within 36 months of the screening visit).

- Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to
screening. Patients who are on a stable dose of SGLT2i may participate if treatment
was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or
ARB may participate if their overall management conforms with standards of care and
other protocol requirements.

- Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0

- eGFR ≥ 30 mL/min/1.73 m^2, (for the exploratory cohort only: eGFR 20- < 30 mL/min/1.73
m^2), calculated using the CKD-EPI equation.)

Exclusion Criteria:

- Secondary forms of IgAN or IgA vasculitis.

- Coexisting chronic kidney disease other than IgAN.

- Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy,
membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are

- Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If
MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or
crescents in > 25% of glomeruli is exclusionary. This does not apply to the
exploratory cohort.

- Nephrotic syndrome

- Serum IgG < 600 mg/dL at screening.

- Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of

- Participation in another interventional clinical trial and receipt of another
investigational drug within 30 days prior to the administration of IMP or 5 half-lives
from last investigational drug administration, whichever is longer.

- Chronic infectious disease, or acute infectious disease at time of screening.

- Type 1 diabetes, or poorly controlled Type 2 diabetes

- Uncontrolled hypertension

The protocol provides additional information about these and other inclusion and exclusion

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Nabeel Aslam, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information


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