This study looks at how well and safely RG002C0106 works for patients with certain kidney disease: primary IgA nephropathy. It's a phase IIa trial done at several locations where both patients and doctors unknow what treatment is being given.
Voluntarily participate in the clinical trial and sign the informed consent form (ICF);
Male or female participants aged 18 to 65 years (inclusive) at the time of signing the ICF;
Body weight ≥ 40 kg;
Negative blood pregnancy test result at screening for female participants of childbearing potential;
Patients with secondary IgA nephropathy ;
Renal biopsy pathology shows renal tubular atrophy or interstitial fibrosis ≥ 50%; or crescent formation in ≥ 50% of glomeruli ;
Acute kidney injury or rapidly progressive glomerulonephritis within 4 weeks prior to screening ;
Patients with nephrotic syndrome, defined as: 24-hour urinary protein (24h-UP) >3.5 g with hypoalbuminemia (serum albumin <3.0 g/dL), hypercholesterolemia (total cholesterol >350 mg/dL), and edema;
Parallel
RG002C0106
DrugRG002C0106 for subcutaneous (SC) injection
placebo subcutaneous administration
DrugThe placebo is made of normal saline.
The percentage change from baseline in the mean 24hUPCR)at Week 24 after the first subcutaneous admini;
Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the investigational drug.
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This trial is not recruiting at the moment. You can still explore other options:
