JRCT ID: jRCT2061230087
Registered date:09/01/2024
A Study to Evaluate the Efficacy and Safety of RO7434656 in Participants with Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression (IMAGINATION)
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Immunoglobulin A nephropathy |
Date of first enrollment | 13/05/2024 |
Target sample size | 428 |
Countries of recruitment | USA,Japan,Poland,Japan,Spain,Japan,France,Japan,Singapore,Japan,Argentina,Japan,Australia,Japan,Brazil,Japan,China,Japan,Germany,Japan,Italy,Japan,Taiwan,Japan,Greece,Japan,Korea,Japan,Czechia,Japan,United Kingdom,Japan,Canada,Japan,Hong Kong,Japan,Malaysia,Japan,Mexico,Japan |
Study type | Interventional |
Intervention(s) | RO7434656: SC doses of either 70 mg of RO7434656 or matching volume of placebo on Days 1, 15, and 29, followed by once every 4 weeks |
Outcome(s)
Primary Outcome | efficacy Change in proteinuria, as measured by the UPCR change at Week 37 from baseline from a 24-hour collection |
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Secondary Outcome | efficacy: Estimated eGFR slope at Week 105 from baseline efficacy: Time to the composite kidney failure endpoint efficacy: Change in fatigue at Week 105 compared with baseline safety: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) phamacokinetics: Plasma Concentration of RO7434656 |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | - Primary IgAN, as evidenced by a kidney biopsy performed within 7 years prior to or during screening, without known secondary cause - Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) for at least 90 days immediately prior to screening - Urine Protein-to-Creatinine Ratio (UPCR) >= 1 gram per gram (g/g) or urine protein excretion >= 1 gram per day (g/day) (with UPCR >= 0.8 g/g), all measured from a 24-hour urine collection during screening obtained no longer than 60 days prior to Day 1 - eGFR >= 20 mL/min/1.73 m^2, as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (Inker et al. 2021a) - Female participants of childbearing potential must use adequate contraception |
Exclude criteria | - Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of RO7434656 - Histopathologic or other evidence of another autoimmune glomerular disease - Presence of >= 50% crescents on kidney biopsy, sustained doubling of serum creatinine within 3 months prior to screening, or rapidly progressive glomerulonephritis in the opinion of the investigator - Glycated Hemoglobin (HbA1c) >= 6.5% or a clinical diagnosis of diabetes mellitus of any type - Uncontrolled blood pressure, in the investigator's assessment, for 3 months prior to screening or during screening - Use of endothelin receptor antagonists, except those approved for use in IgAN - Initiation of mineralocorticoid receptor antagonists or endothelin receptor antagonists within 90 days prior to screening or during screening - Previous treatment with RO7434656 - Use of herbal therapies within 90 days prior to or during screening - Treatment with oral or intravenous (IV) corticosteroids with a dose equivalent to >= 7.5 milligrams per day (mg/day) of prednisone for 7 days or equivalent to >= 5 mg/day of prednisone for 14 days within 90 days prior to screening - Treatment with other immunomodulatory agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), or mycophenolate - Treatment with a calcineurin inhibitor within 2 months prior to screening or during screening - Treatment with anti-CD20 therapy within 9 months of screening or during screening - Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study - Planned major procedure or major surgery during screening or the study |
Related Information
Primary Sponsor | Nikhil Kamath |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05797610 |
Contact
Public contact | |
Name | Clinical trials information |
Address | 1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo Tokyo Japan 103-8324 |
Telephone | +81-120189706 |
clinical-trials@chugai-pharm.co.jp | |
Affiliation | Chugai Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | Nikhil Kamath |
Address | 1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo Tokyo Japan 103-8324 |
Telephone | +81-120189706 |
clinical-trials@chugai-pharm.co.jp | |
Affiliation | F. Hoffmann La Roche Ltd |