Phase IIa Study of RG002C0106 Injection to Treat Primary IgA Nephropathy in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the safety and effectiveness of RG002C0106 in people with primary IgA nephropathy, a specific kidney disease. This Phase IIa study is conducted at multiple centers and uses a double-blind design, in which neither patients nor doctors know who receives the treatment or placebo. The main goal is to see if RG002C0106 can reduce protein in the urine and protect kidney function, along with assessing safety and how the drug behaves in the body. Participants are randomly assigned to receive either the investigational drug RG002C0106 or a placebo, both given by subcutaneous injection. The study lasts up to 169 days, during which patients receive treatment and are monitored closely. The placebo consists of normal saline injections. This design helps compare the effects of RG002C0106 against no active drug while maintaining blinding. During the study, participants undergo various evaluations including urine protein tests over 24 hours and kidney function measurements. Researchers also track any side effects or serious adverse events related to the treatment. Vaccination status and contraception use are monitored to ensure participant safety. The study collects data over about 24 weeks after the first injection to understand how the drug impacts kidney disease and its safety profile.

A Phase IIa Clinical Study of RG002C0106 Injection in Subjects With Primary IgA Nephropathy