What side effects are associated with this type of intervention?

Antisense Oligonucleotide (ASO) therapies, such as those being studied for IgA Nephropathy, have shown promise in reducing kidney damage by modulating gene expression. However, they can have side effects. For instance, inotersen, an ASO used for amyloidosis, has been associated with serious adverse events like glomerulonephritis and severe thrombocytopenia. Other ASO treatments have shown increased albuminuria and potential impacts on kidney function. Patients considering ASO therapies should discuss these potential risks with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

As of now, there are no FDA-approved Antisense Oligonucleotide (ASO) therapies specifically for IgA Nephropathy. Traditional treatments for IgA Nephropathy have included corticosteroids, immunosuppressive drugs, and supportive care such as blood pressure control with ACE inhibitors or ARBs. Recent advancements in the field are exploring novel therapies, including ASOs like RO7434656, which aim to modulate gene expression to reduce kidney damage. These investigational therapies are still under clinical evaluation and have not yet received FDA approval.

What other types of research exist?

Promising alternatives to RO7434656 for IgA Nephropathy patients include other antisense oligonucleotides and RNA interference therapies. These approaches have shown potential in modulating gene expression and reducing kidney damage in various renal diseases. Consulting with a healthcare provider for the latest clinical trials and approved treatments in 2024 is recommended.

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Antisense Oligonucleotide

RO7434656 for IgA Nephropathy (IMAGINATION Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

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 approximately 7 years

Awards & highlights

Summary

This trial is testing a new treatment that uses small genetic pieces to block harmful proteins in people with a specific kidney disease that isn't improving with current treatments. The treatment aims to stop the body from making proteins that make the disease worse.

Who is the study for?

This trial is for adults with primary IgA Nephropathy, a kidney disease, who are at risk of worsening despite current treatments. They must have had a confirming kidney biopsy within the last 7 years and be on stable doses of specific blood pressure medicines. Participants need functioning kidneys (eGFR ≥ 20) and significant protein in their urine. Pregnant women or those planning pregnancy soon after the trial can't join, nor can people with certain diabetes indicators or recent use of strong immune system drugs.

What is being tested?

The study tests RO7434656, an experimental Antisense Oligonucleotide therapy against a placebo to see if it's effective and safe for slowing down kidney disease progression in high-risk IgA Nephropathy patients. The participants will receive either the new drug or a placebo without knowing which one they're getting.

What are the potential side effects?

While specific side effects aren't listed here, antisense oligonucleotides like RO7434656 could potentially cause injection site reactions, flu-like symptoms, changes in liver function tests, and possible impacts on kidney function among others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 7 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 From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37

Secondary study objectives

Change From Baseline in Fatigue at Week 105

Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline

Time to the Composite Kidney Failure Endpoint

Other study objectives

Change From Baseline in Symptoms and Health-Related Quality of Life at Week 105 as Assessed Using the RAND Kidney Disease and Quality of Life 36-Item (KDQOL-36) Short Form

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RO7434656Experimental Treatment1 Intervention

Participants will receive subcutaneous (SC) doses of RO7434656 on Days 1, 15, and 29 followed by once every 4 weeks until Week 105. After Week 105, participants may continue blinded treatment or enter open-label treatment until up to 1 year after the date at which the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive SC doses of RO7434656 matching placebo on Days 1, 15, and 29 followed by once every 4 weeks until Week 105. After Week 105, participants may continue blinded treatment or enter open-label treatment until up to 1 year after the date at which the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.

Do I qualify?Apply below to find out

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 therapies that modulate gene expression to reduce kidney damage. Antisense oligonucleotide (ASO) therapies, like RO7434656, work by binding to specific mRNA sequences to inhibit the production of proteins that contribute to disease progression. For example, ASOs targeting HSP47 can reduce collagen accumulation in glomerulonephritis, while those targeting K-Ras can reduce fibrosis and protect against renal dysfunction. These treatments are significant for IgAN patients as they offer a targeted approach to mitigate the underlying molecular mechanisms driving kidney damage, potentially improving outcomes and slowing disease progression.

Anti-microRNA-21 Therapy on Top of ACE Inhibition Delays Renal Failure in Alport Syndrome Mouse Models.Inhibition of Kirsten-Ras reduces fibrosis and protects against renal dysfunction in a mouse model of chronic folic acid nephropathy.Anticubilin antisense RNA ameliorates adriamycin-induced tubulointerstitial injury in experimental rats.

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Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,444 Previous Clinical Trials

1,092,694 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,212 Previous Clinical Trials

891,988 Total Patients Enrolled

Media Library

RO7434656 (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05797610 — Phase 3

IgA Nephropathy Research Study Groups: Placebo, RO7434656

IgA Nephropathy Clinical Trial 2023: RO7434656 Highlights & Side Effects. Trial Name: NCT05797610 — Phase 3

RO7434656 (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05797610 — Phase 3

~278 spots leftby Sep 2026

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