What is the mechanism of action of this treatment?

Common treatments for IgA Nephropathy include angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which reduce proteinuria and slow disease progression by inhibiting the renin-angiotensin system. Endothelin receptor antagonists are also being explored for their potential to reduce kidney damage by blocking endothelin-1, a molecule involved in inflammation and fibrosis. The antisense inhibitor IONIS-FB-LRx targets complement factor B mRNA, aiming to reduce the activation of the alternative complement pathway, which is implicated in the disease's pathogenesis. These treatments are crucial as they address different aspects of the disease mechanism, potentially improving outcomes and slowing progression for patients with IgA Nephropathy.

What side effects are associated with this type of intervention?

Common treatments for IgA Nephropathy include ACE inhibitors, ARBs, and endothelin receptor antagonists. ACE inhibitors and ARBs can cause side effects such as cough, elevated blood potassium levels, low blood pressure, and kidney dysfunction. Endothelin receptor antagonists may lead to fluid retention, liver function abnormalities, and anemia. For treatments similar to IONIS-FB-LRx, which targets complement factor B mRNA, potential side effects could include injection site reactions, flu-like symptoms, and changes in blood cell counts, although specific side effects for IONIS-FB-LRx are not detailed in the provided context.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for IgA Nephropathy that function as antisense inhibitors of complement factor B mRNA. However, other treatments targeting the complement system, such as eculizumab, have been explored for related conditions. Eculizumab is a monoclonal antibody that inhibits the complement protein C5 and has been approved for conditions like paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). These treatments highlight the potential of complement inhibition in managing kidney diseases, although they are not specifically approved for IgA Nephropathy.

What other types of research exist?

Promising novel alternatives to IONIS-FB-LRx for IgA Nephropathy patients include obinutuzumab, a type II anti-CD20 monoclonal antibody, which has shown improved renal responses in lupus nephritis and may offer benefits in IgA Nephropathy. Additionally, eculizumab, a complement inhibitor, has been effective in other complement-mediated kidney diseases and could be considered.

← Back to Search

Antisense Inhibitor

IONIS-FB-LRx for IgA Nephropathy

Phase 2

Waitlist Available

Research Sponsored by Ionis Pharmaceuticals, 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

Active infection 30 days prior to study

Clinically significant abnormalities in medical history (e.g., dementia, stroke, acute coronary syndrome, thrombocytopenia, or major surgery within 3 months of Screening)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests IONIS-FB-LRx, a drug that lowers harmful protein levels, in people with IgA nephropathy to see if it can protect their kidneys.

Who is the study for?

Adults with confirmed primary IgA nephropathy, a kidney disease marked by blood and protein in urine, can join this trial. They must not be pregnant or breastfeeding and should use effective birth control if necessary. People with recent major health events, certain immune deficiencies, severe infections, very low kidney function, or other specific kidney diseases cannot participate.

What is being tested?

The trial is testing IONIS-FB-LRx's ability to safely treat IgA nephropathy by inhibiting complement factor B. It will also assess how the drug affects plasma factor B levels and serum activity related to the body's defense (complement) system.

What are the potential side effects?

While specific side effects of IONIS-FB-LRx are not listed here, antisense drugs like it may cause injection site reactions, flu-like symptoms, potential liver issues and changes in blood test results.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have not had any infections in the last 30 days.

Select...

I have not had a major illness like a stroke or heart attack, or major surgery in the last 3 months.

Select...

I have a weak immune system due to a B-cell problem, had my spleen removed, or had meningitis more than once.

Select...

I have a kidney condition besides my main diagnosis.

Select...

My kidney function is low, with an eGFR of 40 mL/min/1.73m^2 or less.

Select...

I have had a kidney or other organ transplant.

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: IONIS-FB-LRxExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IONIS-FB-LRx

2019

Completed Phase 2

~30

0 / 6Eligibility 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

Common treatments for IgA Nephropathy include angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which reduce proteinuria and slow disease progression by inhibiting the renin-angiotensin system. Endothelin receptor antagonists are also being explored for their potential to reduce kidney damage by blocking endothelin-1, a molecule involved in inflammation and fibrosis. The antisense inhibitor IONIS-FB-LRx targets complement factor B mRNA, aiming to reduce the activation of the alternative complement pathway, which is implicated in the disease's pathogenesis. These treatments are crucial as they address different aspects of the disease mechanism, potentially improving outcomes and slowing progression for patients with IgA Nephropathy.

Intravenous immunoglobulin in the management of lupus nephritis.Meta-analysis of antiplatelet therapy for IgA nephropathy.