What side effects are associated with this type of intervention?

Common treatments for IgA Nephropathy, such as ACE inhibitors and ARBs, are generally well-tolerated but can cause side effects like cough, dizziness, and hyperkalemia. Immunosuppressive agents, including glucocorticoids, can lead to serious infections, impaired glucose tolerance, weight gain, and other metabolic disturbances. Mycophenolate mofetil (MMF) may cause gastrointestinal issues, infections, and hematologic abnormalities. These side effects highlight the importance of careful monitoring and individualized treatment plans.

What prior FDA approvals exist?

Currently, there are no FDA-approved therapies specifically for IgA Nephropathy. Treatments under investigation, such as Sibeprenlimab, aim to reduce proteinuria and preserve kidney function. Other monoclonal antibodies like rituximab have been studied for their potential benefits in similar renal conditions, but they have not shown significant efficacy in IgA Nephropathy. The ongoing research into drugs like Sibeprenlimab represents a promising area for future therapeutic options.

What other types of research exist?

Promising alternatives to Sibeprenlimab for IgA Nephropathy patients include: 1) Rituximab, an anti-CD20 monoclonal antibody, which has shown efficacy in treating nephrotic syndromes including IgAN. 2) Eculizumab, an anti-C5 monoclonal antibody, which theoretically could be efficacious in humoral antibody syndromes where complement activation is involved. 3) Avacopan, a C5a receptor antagonist, approved for ANCA-associated vasculitis, which may have potential in IgAN due to its mechanism of action on the complement system.

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Monoclonal Antibodies

Sibeprenlimab for IgA Nephropathy

Phase 3

Waitlist Available

Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Nephrotic syndrome

Uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial tests injections of sibeprenlimab in adults with IgA Nephropathy who are on standard treatment. The drug aims to reduce harmful proteins in urine and help maintain kidney function.

Who is the study for?

Adults with IgA Nephropathy (IgAN) who've been on a stable dose of certain kidney medications for at least 3 months can join. They need to have a specific level of protein in their urine and their kidneys must be functioning above a certain threshold. People with other kidney diseases, uncontrolled diabetes or hypertension, or those on recent immunosuppressants can't participate.

What is being tested?

The trial is testing Sibeprenlimab, given as an injection every four weeks, against a placebo. Participants also continue their usual care for IgAN. The study aims to see if Sibeprenlimab helps reduce protein in the urine and affects kidney function over time.

What are the potential side effects?

Potential side effects of Sibeprenlimab are not detailed here but may include reactions similar to other immune-modulating drugs such as injection site reactions, increased risk of infections, and possible impacts on liver function.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with nephrotic syndrome.

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My high blood pressure is not under control.

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I have Type 1 diabetes or my Type 2 diabetes is not well-controlled.

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I have chronic kidney disease, but it's not IgA nephropathy.

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I have a long-term infection or a current infection.

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My kidney biopsy shows specific damage levels according to the Oxford classification.

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My condition is related to IgA nephropathy or IgA vasculitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Sibeprenlimab 400 mg s.c. q 4weeksActive Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 7Eligibility 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 IgA Nephropathy (IgAN) include angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which reduce proteinuria and protect kidney function by lowering blood pressure and decreasing glomerular pressure. Endothelin receptor antagonists target endothelin-1, a molecule that contributes to kidney damage through vasoconstriction and inflammation. Immunosuppressive therapies, such as systemic glucocorticoids, reduce inflammation and immune response, potentially slowing disease progression. These treatments are crucial for IgAN patients as they help manage proteinuria and preserve kidney function, which are key indicators of disease progression and overall prognosis.

Antithrombotic drug therapy for IgA nephropathy: a meta analysis of randomized controlled trials.Treatment for IgA nephropathy.Meta-analysis of antiplatelet therapy for IgA nephropathy.

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Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor

264 Previous Clinical Trials

169,550 Total Patients Enrolled

Media Library

Sibeprenlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05248646 — Phase 3

IgA Nephropathy Research Study Groups: Sibeprenlimab 400 mg s.c. q 4weeks, Placebo

IgA Nephropathy Clinical Trial 2023: Sibeprenlimab Highlights & Side Effects. Trial Name: NCT05248646 — Phase 3

Sibeprenlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05248646 — Phase 3

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