A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria
ConditionIgA Nephropathy (IgAN)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiocity Biopharmaceutics Co., Ltd.
About this trial
This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of SC0062 capsule compared to placebo in patients with IgA nephropathy in the presence of proteinuria. The participants must have a high risk of disease progression, despite of stable use of the maximum tolerated labelled or optimized dose of RAASi and/or SGLT2i for at least 12 weeks prior to randomization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily sign informed consent and fully understand and comply with trial procedures;
Age ≥18 years old, gender unlimited;
According to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI, 2009) creatinine equation, after 12 weeks of the stable use of the background therapy, the mean of two estimated glomerular filtration rates (eGFR) calculated from central laboratory results was ≥ 30 and < 90 mL/min/1.73m2.
Received the maximum labeled or tolerated dose of RAASi (ACEI or ARB) for at least 12 weeks before randomization; If subjects were treated with SGLT2i, MRA, or GLP-1RA prior to randomization, the stable use was also required for at least 12 weeks (maximum tolerated and optimal dose determined by the investigator; Subjects who are intolerant to RAASi may also be enrolled).
Disqualifiers
Pregnant or lactating females; Women of childbearing potential (WOCBP) who have a positive blood pregnancy test before randomization;
A history of hypersensitivity or allergic to any component of the study drug (SC0062 capsule);
Systemic use of corticosteroids or immunosuppressants for more than 2 weeks within 3 months prior to randomization; The following are excluded: local topical or intraarticular, intranasal and inhaled glucocorticoids; Use of biological agents (such as rituximab, Telitacicept, etc.), Iptacopan capsules, budesonide enteric-coated capsules within 6 months prior to randomization;
Concurrent diagnosis of chronic kidney disease caused by other etiologies (including polycystic kidney disease, diabetic kidney disease, or other primary glomerular disease) as determined by the investigator;
Trial design
Design model
Parallel
Treatments tested in this trial
SC0062 strength 10mg
DrugSubjects will take 20 mg once daily for 108 weeks during the treatment period.
Placebo matched to SC0062
DrugSubjects will take 20 mg once daily for 108 weeks during the treatment period.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: SC0062 groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 36 weeks
UPCR is measured from the 24-hour urine collection samples.
Time frame
Baseline, 36 weeksSecondary outcomes
1
Change from baseline in estimated glomerular filtration rate (eGFR) at 108 weeks
Estimated glomerular filtration rate (eGFR) will be calculated based on the 2009 CKD-EPI equation.
Time frame
Baseline, 108 weeks2
The total slope of estimated glomerular filtration rate (eGFR) from baseline to 108 weeks
the total eGFR slope is defined as the mean rate of change in eGFR from baseline to 108 weeks
Time frame
Each visit from baseline to 108 weeksSponsors and contacts
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Source ClinicalTrials.gov