IgA Nephropathy
Conditions
Interventions
placebo:placebo
Test group:BION-1301
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged >= 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures. 2. Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Medical Monitor. 3. eGFR >= 30 mL/min/1.73m^2 at Screening based on the 2021 CKD-EPI equation (for the exploratory cohort only: eGFR of >= 20 to = 1.0 g/day and UPCR >= 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory. 5. Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi)/ angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi/ARB. May also be on a stable and well tolerated dose of sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or endothelin receptor antagonists (ERAs)/ mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on the ACEi/ARB, SGLT2i, and/or the ERAs/MRAs for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias. 2. Diagnosis of IgA Vasculitis. 3. Current or history of nephrotic syndrome. 4. Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for > 14 days within 12 weeks prior to Screening. 5. Use of systemic immunosuppressant medications including mycophenolate, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, etc. for > 2 weeks in the past 12 weeks prior to Screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy; | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of BION-1301 versus placebo on estimated glomerular filtration rate (eGFR);To evaluate the effect of BION-1301 versus placebo on specific clinical composite endpoints during the study; | — |
Countries
China
Contacts
Public ContactYe Zhiming
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed