A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetic/Pharmacodynamic Characteristics of RG002C0106 Injection in Subjects With Primary IgA Nephropathy
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;
• Renal biopsy pathology results within 10 years prior to screening confirming a diagnosis of primary IgA nephropathy;
• 24-hour urinary protein ≥ 0.75 g/24 h during the screening period;
• Estimated glomerular filtration rate (eGFR) (calculated using the creatinine-based CKD-EPI formula) ≥ 30 mL/min/1.73 m² during the screening period;
• Must have received vaccination against Neisseria meningitidis (serogroups A, C, W, Y) and Streptococcus pneumoniae infections at least 2 weeks prior to the first dose of the investigational product and provide proof of such vaccination;
• Participants must agree and require their partners to use adequate contraception from the time of signing the ICF, throughout the study, and for at least 3 months after the study ends . Male participants must not donate sperm for at least 6 months after the last dose of the investigational product.