Actively Recruiting
A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria
Led by Biocity Biopharmaceutics Co., Ltd. · Updated on 2025-02-17
360
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Patients with confirmed IgA nephropathy and proteinuria
- Estimated glomerular filtration rate (eGFR) between 30 and less than 90 mL/min/1.73m2 after 12 weeks of stable background therapy
- Stable use of maximum labeled or tolerated dose of RAAS inhibitors for at least 12 weeks before randomization; stable use of SGLT2 inhibitors, MRA, or GLP-1RA also required if applicable
- Two 24-hour urine samples showing protein-to-creatinine ratio ≥ 0.75 g/g or urinary protein excretion rate ≥ 1.0 g after stable treatment
- Serum albumin ≥ 30 g/L
- Hemoglobin ≥ 90 g/L and platelet count ≥ 80×10⁹/L
- Brain natriuretic peptide ≤ 200 pg/mL or NT-proBNP ≤ 600 pg/mL
- Blood potassium ≤ 5.5 mmol/L
- Systolic blood pressure ≤ 160 mmHg
- Hemoglobin A1c ≤ 8%
- ALT and AST ≤ 2 times upper limit of normal; total bilirubin ≤ 1.5 times upper limit of normal
- Fertile males and females must agree to use effective contraception from consent signing until 3 months after final dose
You will not qualify if you...
- Pregnant or breastfeeding women; positive pregnancy test before randomization
- History of allergy to SC0062 capsule components
- Systemic corticosteroids or immunosuppressants use over 2 weeks within 3 months before randomization; use of biological agents or certain other medications within 6 months
- Chronic kidney disease from other causes (e.g., diabetic kidney disease, polycystic kidney disease)
- Secondary IgA nephropathy from other diseases (e.g., lupus, amyloidosis)
- Renal biopsy showing > 25% crescents or > 50% interstitial fibrosis/tubular atrophy
- Suspected rapidly progressive glomerulonephritis
- Nephrotic syndrome at screening (proteinuria > 3.5 g/day and serum albumin < 30 g/L)
- History of lung diseases requiring oxygen therapy
- Prior use of endothelin receptor antagonists before randomization
- History of moderate or severe edema or facial edema within 6 months
- History of orthostatic hypotension within 6 months
- Clinically significant cirrhosis
- Recent serious cardiovascular or cerebrovascular events within 6 months or NYHA Class III-IV heart failure
- History of organ transplantation (except corneal)
- Conditions interfering with oral drug absorption
- Use of potent CYP3A4 inducers or inhibitors within 14 days before randomization
- Recent treatments for IgA nephropathy not permitted by protocol
- Active infections such as Hepatitis B, C, syphilis, or HIV
- History of malignancy within 5 years except certain skin, cervical, thyroid, or colon conditions
- History of substance abuse or mental illness
- Participation in other clinical trials within 3 months
- Any other conditions that may affect safety or study evaluation as judged by the investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
Y
Ye Zhiming, Prof
CONTACT
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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