NCT07305974

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rigerna Therapeutics Co., Ltd.; Rigerna Therapeutics (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a Phase IIa, multicenter, double-blind clinical trial designed to evaluate the efficacy and safety of RG002C0106 in patients with primary IgA nephropathy. The primary objective is to assess the efficacy of RG002C0106 in reducing urinary protein excretion and preserving renal function in these patients. Secondary objectives include characterization of the safety profile, pharmacokinetics, and pharmacodynamics of the treatment

Conditions

• IgA Nephropathy (IgAN)

Interventions

Type	Name	Description
DRUG	RG002C0106	RG002C0106 for subcutaneous (SC) injection
DRUG	placebo subcutaneous administration	The placebo is made of normal saline.

Timeline

• Start date: 2025-09-08
• Primary completion: 2029-03-31
• Completion: 2029-03-31
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: China