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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
IMAGINATION Trial 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.
IMAGINATION Trial 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
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 moreOther 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
IMAGINATION 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.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,733 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,450 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have too much protein in your urine, which can be measured from a 24-hour urine collection during screening.My kidney disease is rapidly worsening, as shown by tests or doctor's opinion.I have not had anti-CD20 therapy in the last 9 months.I am using effective birth control methods.My HbA1c level is 6.5% or higher, or I have been diagnosed with diabetes.I have not taken calcineurin inhibitors in the last 2 months.I am not using any endothelin receptor antagonists not approved for IgAN.My kidney biopsy confirms primary IgA nephropathy within the last 7 years.I have been treated with RO7434656 before.I am scheduled for a major surgery or procedure during the study.I do not have any serious health issues that would make it unsafe for me to join the study.I have been on the highest dose I can handle of ACE inhibitors or ARBs for the last 3 months.I haven't taken any immune system modifying drugs in the last 6 months.I started taking specific heart or blood pressure medication within the last 90 days.I have been on steroids equivalent to 7.5mg of prednisone daily for a week or 5mg daily for two weeks in the last 3 months.I have not used herbal therapies in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: RO7434656
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks have been identified with the use of RO7434656?
"RO7434656 has a safety rating of 3 as there is sufficient clinical evidence to support efficacy and multiple data points confirming its safety profile."
Answered by AI
Is recruitment currently ongoing for this experiment?
"Affirmative. According to clinicaltrials.gov, the study is actively seeking participants since it was first posted on June 30th 2023 and recently updated on May 16th 2023. There are two trial sites looking for 428 volunteers in total."
Answered by AI
How many subjects are taking part in this research study?
"Affirmative. The latest information provided by clinicaltrials.gov reveals that this medical research is actively searching for 428 volunteers across two sites, with the trial having been initially posted on June 30th 2023 and updated most recently on May 16th 2023."
Answered by AI
Who else is applying?
What site did they apply to?
R & H Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
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