History of Changes for Study: NCT05852938

A Study of BION-1301 in Adults With IgA Nephropathy

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Study Record Versions

Version	Submitted Date	Changes
1	May 2, 2023	None (earliest Version on record)
2	July 12, 2023	Recruitment Status, Study Status, Contacts/Locations, Study Design and Oversight
3	January 12, 2024	Contacts/Locations and Study Status
4	March 18, 2024	Contacts/Locations and Study Status
5	April 17, 2024	Study Status, Eligibility and Study Description
6	May 17, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CHK02-02
Brief Title:	A Study of BION-1301 in Adults With IgA Nephropathy
Official Title:	A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Secondary IDs:

Study Status


Record Verification:	May 2023
Overall Status:	Not yet recruiting
Study Start:	July 1, 2023
Primary Completion:	July 1, 2026 [Anticipated]
Study Completion:	May 1, 2028 [Anticipated]

First Submitted:	May 2, 2023
First Submitted that Met QC Criteria:	May 2, 2023
First Posted:	May 10, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	May 2, 2023
Last Update Posted:	May 10, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Chinook Therapeutics, Inc.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

Brief Summary:

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Detailed Description:

Approximately 272 patients with eGFR ≥ 30 mL/min/1.73m2 and with biopsy-proven IgAN will be randomized to receive 600mg Q2W BION-1301 or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 subjects (10 subjects per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to < 30 mL/min/1.73 m2.

The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy.

Subjects will have assessments of safety and efficacy for 2.5 years (up to 134 weeks). To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.

Conditions


Conditions:	IgA Nephropathy Immunoglobulin A Nephropathy
Keywords:	Kidney Diseases Kidney Diseases, Chronic Urological Diseases Glomerulonephritis Glomerular Disease Glomerulonephritis, IGA Glomerulopathy Immunoglobulin Disease

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	272 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: BION-1301 600mg subcutaneous administration every 2 weeks for 104 weeks	Drug: BION-1301 BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks. Other Names: Zigakibart
Placebo Comparator: Placebo subcutaneous administration every 2 weeks for 104 weeks	Drug: Placebo Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.

Outcome Measures


Primary Outcome Measures:
1.	Change in proteinuria [ Time Frame: 40 weeks or approximately 9 months ] The change in urine protein: creatinine ratio (UPCR) from baseline to Week 40.
Secondary Outcome Measures:
1.	Change in eGFR [ Time Frame: 104 weeks or approximately 2 years ] The change in eGFR from baseline to Week 104.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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.

Contacts/Locations


Locations:

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: