Overview
A Study of BION-1301 in Adults With IgA Nephropathy
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2028-05-01
2028-05-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Safety and Efficacy of BION-1301 in Adults with IgA NephropathyPhase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Chinook Therapeutics, Inc.
Criteria
Inclusion Criteria:- 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.
- Biopsy-proven IgAN within the past 10 years that is not due to secondary causes. A
pseudonymized copy of the report must be available for review. If biopsy report within
10 years is not available, re-biopsy may be permitted upon discussion with the Medical
Monitor.
- eGFR ≥ 30 mL/min/1.73m2 at Screening based on the 2021 CKD-EPI equation (for the
exploratory cohort only: eGFR of ≥20 to < 30 mL/min/1.73 m2).
- Total urine protein ≥ 1.0 g/day and UPCR ≥ 0.7 g/g, as measured from an adequate
24hour urine collection at Screening by a central laboratory.
- Stable on a maximally tolerated dose of ACEi/ARB for at least 12 weeks prior to
Screening or intolerant to ACEi/ARB; may also be on a stable and well tolerated dose
of SGLT2i and/or ERAs/MRAs for at least 12 weeks prior to Screening for the treatment
of IgAN.
- Body mass index (BMI) between 18 and 40 kg/m2.
- Screening weight of at least 50 kg.
- Men and women of childbearing potential must agree to follow protocol-specified
contraception guidance from Screening through approximately 5 half-lives after the
final dose of study drug. Provide written informed consent and be willing to comply
with study visits and procedures.
Exclusion Criteria:
- Secondary forms of IgAN as determined by the Investigator, in the setting of systemic
disorders, infections, autoimmune disorders or neoplasias.
- Diagnosis of IgA Vasculitis or current or history of nephrotic syndrome
- Average blood pressure (BP) > 150/90 mm Hg (systolic/diastolic). Clinical suspicion of
IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines
(KDIGO, 2021)
- Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from
any condition or another glomerulopathy/podocytopathy other than IgAN.
- History of Type 1 Diabetes.
- Subjects with Type 2 diabetes are excluded if any of the following are present:
- Screening HbA1c of > 8%.
- Evidence of diabetic changes on kidney biopsy, performed for any reason.
- History of diabetic microvascular/macrovascular disease. Unstable anti-diabetic
regimen
- Prior exposure to any antibody directed against APRIL.
- History of a previous severe allergic reaction including a history of severe
hypersensitivity reaction to any monoclonal antibody.
- Received an investigational new drug within 28 days or 5 half-lives, whichever is
longer, prior to Screening.
- Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for
>14 days within 12 weeks prior to Screening.
- Use of systemic immunosuppressant medications
- Current severe infection requiring antimicrobials or history of recurrent, severe,
infections as determined by the Investigator.
- Positive serology test for HIV or hepatitis infection.
- Received a live vaccination within 12 weeks prior to Screening or plan to have a live
vaccination within 6 months after the last dose of study drug.
- Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the
study period and until 24 weeks after last dose.
- Participation in another interventional trial with an investigational agent/device is
prohibited during the course of this study.