A Study to Evaluate the Efficacy and Safety of RO7434656 in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression (IMAGINATION)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05797610|
Recruitment Status : Recruiting
First Posted : April 4, 2023
Last Update Posted : November 3, 2023
|Condition or disease||Intervention/treatment||Phase|
|Primary IgA Nephropathy||Drug: RO7434656 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||428 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RO7434656, an Antisense Inhibitor of Complement Factor B, in Patients With Primary IgA Nephropathy at High Risk of Progression|
|Actual Study Start Date :||August 8, 2023|
|Estimated Primary Completion Date :||September 30, 2026|
|Estimated Study Completion Date :||September 30, 2030|
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 up to 1 year after the date at which the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.
RO7434656 will be administered subcutaneously per schedule as specified.
Placebo Comparator: Placebo
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 up to 1 year after the date at which the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.
Matching placebo will be administered subcutaneously per schedule as specified.
- Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37 [ Time Frame: Baseline, Week 37 ]UPCR will be assessed in urine sampled over 24 hours.
- Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline [ Time Frame: Baseline, Week 105 ]eGFR will be calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.
- Time to the Composite Kidney Failure Endpoint [ Time Frame: Up to approximately 7 years ]Time to the composite kidney failure endpoint is defined as receipt of kidney transplantation, need for kidney replacement therapy, or a sustained decline in eGFR of ≥ 30% (requires two consecutive central laboratory eGFR values meeting criteria ≥ 4 weeks apart), whichever occurs first, without the receipt of other immunosuppressive or background therapies for the treatment of IgAN.
- Change From Baseline in Fatigue at Week 105 [ Time Frame: Baseline, Week 105 ]Fatigue will be assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F). The FACIT-F Scale is a 13-item scale used to measure self-reported fatigue. Items are assessed on a 5-point Likert scale, with responses ranging from 0 for "not at all" to 4 for "very much". The total raw score is the sum of the values of each scored question and ranges from 0 to 52. A higher score indicates less fatigue.
- Change From Baseline in Symptoms and Health-Related Quality of Life at Week 105 as Assessed Using the Kidney Disease and Quality of Life 36-Item (KDQOL-36) Short Form [ Time Frame: Baseline, Week 105 ]The KDQOL-36 is an abbreviated questionnaire that combines generic and disease-specific components to assess participant's health-related quality of life. This 36-item questionnaire includes the Short Form 12 (SF-12), Version 1 (12 items) and 3 disease-related domains, symptoms/problems (12 items), burden of kidney disease (4 items), and effects of kidney disease (8 items). It uses a recall of 4 weeks, and items are assessed on 3- to 5-point Likert scales or with a dichotomous response option. Higher score indicates better health. The raw scores are transformed linearly to a range of 0 to 100, with higher scores indicating better health.
- Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 7 years ]
- Plasma Concentration of RO7434656 [ Time Frame: Up to approximately 7 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05797610
|Contact: WA43966 https://forpatients.roche.com/||888-662-6728 (U.S. Only)||firstname.lastname@example.org|
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|Reno, Nevada, United States, 89511|
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|North Carolina Nephrology, PA||Recruiting|
|Raleigh, North Carolina, United States, 27609|
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|Nephrology Associates of Northern Virginia Inc||Recruiting|
|Fairfax, Virginia, United States, 22033|
|Study Director:||Clinical Trials||Hoffmann-La Roche|