What side effects are associated with this type of intervention?

Common treatments for Immunoglobulin A Nephropathy (IgAN) include glucocorticoids, mycophenolate mofetil (MMF), and cyclophosphamide. Glucocorticoids can cause serious adverse events such as severe infections and hospitalization, particularly at high doses. Mycophenolate mofetil may lead to gastrointestinal issues, infections, and hematologic abnormalities. Cyclophosphamide is associated with risks of bone marrow suppression, infections, and potential long-term risks like infertility and secondary malignancies. The treatment being studied in the trial BION-1301 involves the inhibition of APRIL, which is a novel approach, and specific side effects are not detailed in the provided context. However, as with any immunosuppressive therapy, potential side effects could include increased susceptibility to infections and other immune-related complications.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments that target APRIL inhibition for Immunoglobulin A Nephropathy (IgAN). However, various other treatments have been explored and used, including corticosteroids, immunosuppressive agents like mycophenolate mofetil, and targeted-release budesonide. These treatments aim to reduce proteinuria and manage the progression of the disease. BION-1301, which is being studied for its potential to inhibit APRIL, represents a novel approach in the treatment landscape of IgAN.

What other types of research exist?

Promising novel alternatives to BION-1301 for IgA Nephropathy patients include enteric-budesonide, which has shown potential efficacy in reducing proteinuria, and corticosteroids, which have demonstrated a decreased risk of renal function decline despite a higher risk of adverse events. Rituximab and mycophenolate mofetil have shown conflicting results and may not be as promising.

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Monoclonal Antibodies

BION-1301 for IgA Nephropathy

Phase 3

Recruiting

Research Sponsored by Chinook Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Screening weight of at least 50 kg.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 104 weeks or approximately 2 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing BION-1301, a new medication, in adults with IgA nephropathy. The goal is to see if it can help reduce the amount of protein leaking into their urine by improving kidney function.

Who is the study for?

Adults over 18 with IgA Nephropathy, weighing at least 50 kg, can join this trial. They must agree to use contraception and follow the study's procedures. People using immunosuppressants, with severe allergies to monoclonal antibodies, diabetic complications, or a history of Type 1 Diabetes cannot participate.

What is being tested?

The trial is testing BION-1301 for safety and effectiveness in treating IgA Nephropathy compared to a placebo (a substance with no active drug). Participants will be randomly assigned to receive either BION-1301 or the placebo.

What are the potential side effects?

Possible side effects of BION-1301 may include allergic reactions due to its nature as a monoclonal antibody. Specific side effects are not listed but typically could involve immune system responses or infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years or older and have signed the consent form.

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I weigh at least 50 kg.

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I agree to use birth control as directed and follow the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 104 weeks or approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~104 weeks or approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 104 weeks or approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in proteinuria (natural log UPCR)

Secondary study objectives

Change in eGFR

Effect of BION-1301 on specific clinical composite endpoints (30% eGFR reduction)

Effect of BION-1301 on specific clinical composite endpoints (40% eGFR reduction)

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BION-1301Experimental Treatment1 Intervention

600mg subcutaneous administration every 2 weeks for 104 weeks

Group II: PlaceboPlacebo Group1 Intervention

subcutaneous administration every 2 weeks for 104 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BION-1301

2022

Completed Phase 1

~40

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Immunoglobulin A Nephropathy (IgAN) include angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), corticosteroids, and immunosuppressive agents. These treatments primarily aim to reduce proteinuria and control blood pressure, thereby slowing disease progression. The inhibition of APRIL (A Proliferation-Inducing Ligand), as studied in the BION-1301 trial, targets a specific pathway involved in the production of IgA antibodies. By inhibiting APRIL, the treatment aims to reduce the levels of pathogenic IgA, which is crucial in preventing the formation of immune complexes that damage the kidneys. This targeted approach is significant for IgAN patients as it addresses the underlying cause of the disease, potentially offering a more effective and specific treatment option compared to broader immunosuppressive therapies.