Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SC0062 Capsule in Patients with IgA Nephropathy and Proteinuria
Led by Biocity Biopharmaceutics Co., Ltd. · Updated on 2025-02-17
360
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of SC0062 capsules compared to a placebo in adults with IgA nephropathy who have proteinuria and are at high risk of disease progression. This Phase III, multicenter, randomized, double-blind, placebo-controlled study focuses on patients who have been on stable, maximum tolerated doses of RAAS inhibitors and/or SGLT2 inhibitors for at least 12 weeks before starting the trial. Participants will be randomly assigned to take either SC0062 capsules or placebo capsules once daily, alongside their regular background medications, for a treatment period of 108 weeks. Both groups will take two capsules daily during this time. The study aims to carefully monitor changes in kidney function and protein levels in urine over the treatment period. During the study, participants will undergo regular assessments including measurements of 24-hour urine protein-to-creatinine ratio at baseline and 36 weeks, as well as estimated glomerular filtration rate (eGFR) at baseline and 108 weeks. These evaluations help researchers monitor kidney health and disease progression. Safety will be closely observed throughout the study, which may last several years until final follow-up in 2028.
CONDITIONS
Brief Title
A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and understand trial procedures
- Age 18 years or older, any gender
- Diagnosed with IgA nephropathy confirmed by pathological examination
- Estimated glomerular filtration rate (eGFR) between 30 and less than 90 mL/min/1.73m2 after 12 weeks of stable background therapy
- On maximum labeled or tolerated dose of RAAS inhibitors (ACEI or ARB) for at least 12 weeks before randomization; stable use of SGLT2i, MRA, or GLP-1RA also required if applicable
- Proteinuria confirmed by two 24-hour urine samples with UPCR ≥ 0.75 g/g or UPER ≥ 1.0 g
- Laboratory values within specified ranges: serum albumin ≥ 30 g/L, hemoglobin ≥ 90 g/L, platelet count ≥ 80×10^9/L, BNP ≤ 200 pg/mL or NT-proBNP ≤ 600 pg/mL, blood potassium ≤ 5.5 mmol/L, systolic blood pressure ≤ 160 mmHg, hemoglobin A1c ≤ 8%, liver enzymes and bilirubin within limits
- Fertile males and females must use effective contraception from consent until 3 months after last dose
You will not qualify if you...
- Pregnant or breastfeeding females; positive pregnancy test before randomization
- Allergy or hypersensitivity to SC0062 capsule components
- Use of systemic corticosteroids or immunosuppressants for more than 2 weeks within 3 months before randomization
- Diagnosis of chronic kidney disease from other causes or secondary IgA nephropathy
- Renal biopsy showing >25% glomeruli with crescents or >50% interstitial fibrosis/tubular atrophy
- Suspected rapidly progressive glomerulonephritis
- Nephrotic syndrome at screening
- History of lung disease requiring oxygen therapy
- Use of endothelin receptor antagonists before randomization
- History of significant edema, orthostatic hypotension, cirrhosis, serious cardiovascular or cerebrovascular disease within 6 months
- History of organ transplantation except corneal
- Conditions affecting oral drug absorption
- Use of potent CYP3A4 inducers or inhibitors within 14 days before randomization
- Treatment for IgA nephropathy within 28 days before randomization not allowed
- Active hepatitis B or C, syphilis, or HIV infection
- History of malignant tumors within 5 years except certain non-invasive cancers
- History of alcohol or drug abuse or mental illness
- Participation in other investigational trials within 3 months before randomization
- Any other condition that may affect safety or study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 108 weeks
Participants take SC0062 capsules or placebo daily along with background medication.
Regular visits throughout the 108 weeks
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Yuexiu District, China, 510800
Actively Recruiting
Research Team
Y
Yu Xueqing, Prof
Y
Ye Zhiming, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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