What side effects are associated with this type of intervention?

Common treatments for IgA Nephropathy, particularly monoclonal antibodies like Sibeprenlimab, often target immune pathways. Known side effects of these treatments can include infusion-related reactions such as headache, chills, dizziness, and fluid retention. More severe but less common side effects may include acute renal failure, thrombotic events (e.g., myocardial infarction, stroke, pulmonary embolism), and anaphylaxis, especially in patients with underlying renal insufficiency or IgA deficiency. It is important to monitor patients closely for these potential adverse effects.

What prior FDA approvals exist?

There is limited information on prior FDA approvals specifically for IgA Nephropathy treatments similar to Sibeprenlimab. However, monoclonal antibodies like Rituximab have been studied for their efficacy in treating immune-mediated renal diseases, including IgA Nephropathy. Rituximab targets B cells, which play a role in the pathogenesis of various glomerular diseases. Other immune-modulating therapies, such as corticosteroids and angiotensin inhibition, are commonly used to manage IgA Nephropathy, but specific monoclonal antibodies targeting immune pathways in this condition are still under investigation.

What other types of research exist?

Promising alternatives to Sibeprenlimab for IgA Nephropathy patients include rituximab, which has shown efficacy in various glomerulonephritis conditions by depleting B cells. Additionally, newer anti-CD20 agents and therapies targeting B lymphocyte stimulator are under evaluation and may offer effective treatment options.

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Monoclonal Antibodies

Sibeprenlimab for IgA Nephropathy

Phase 2 & 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of sibeprenlimab, an injectable medication, in patients with IgA Nephropathy who have been part of earlier studies. The medication likely helps manage symptoms or slow disease progression. Sibeprenlimab is being developed as a potential treatment for IgA nephropathy (IgAN).

Who is the study for?

This trial is for people with a kidney condition called IgA Nephropathy who have a certain level of kidney function (eGFR ≥ 20 mL/min/1.73 m2) and completed previous trials without safety issues. It's not open to those who didn't finish the earlier studies or developed conditions that would have excluded them.

What is being tested?

The study tests Sibeprenlimab, given as an injection under the skin every four weeks, to see how safe and effective it is over time for treating IgA Nephropathy.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to Sibeprenlimab since assessing long-term safety and tolerability is one of the main goals of this phase.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sibeprenlimab 400 mg s.c. q 4 weeksExperimental Treatment1 Intervention

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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

Common treatments for IgA Nephropathy (IgAN) include angiotensin inhibition (e.g., enalapril, valsartan), which reduces proteinuria and protects kidney function by lowering blood pressure and decreasing glomerular pressure. Monoclonal antibodies like rituximab and sibeprenlimab target specific immune pathways, such as B-cell depletion or other immune modulators, to reduce inflammation and immune complex deposition in the kidneys. Aliskiren, a direct renin inhibitor, also helps in reducing proteinuria. These treatments are crucial for IgAN patients as they address the underlying immune dysregulation and proteinuria, which are key factors in disease progression and kidney damage.

Rituximab In The Treatment Of Refractory Idiopathic Membranous Nephropathy In Pakistani Population.Successful Use of Aliskiren in a Case of IgA- Mesangial Glomerulonephritis Unresponsive to Conventional Therapies.Alemtuzumab Induction and Steroid Minimization in IgA Nephropathy: A Matched-Cohort Analysis.