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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 studies a new drug to help people with IgA nephropathy reduce risk of kidney damage.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37
Secondary outcome measures
Change From Baseline in Fatigue at Week 105
Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline
Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
+2 more
Other outcome measures
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.

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.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,436 Previous Clinical Trials
1,091,207 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
889,878 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
~285 spots leftby Sep 2026