This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of SHR-2173 in patients with Primary IgA Nephropathy(IgAN). The study consists of a screening period, a run-in period, a 48-week double-blind treatment period, and a 12-week follow-up period. Approximately 84 IgAN patients will be included.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
SHR-2173 injection;High dose
SHR-2173 injection;Medium dose
SHR-2173 injection;Low dose
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Change from baseline in 24-hour Urine Protein-to-Creatinine Ratio (UPCR) at Week 24.
Time frame: Week 24.
Change from baseline in 24-hour UPCR ;
Time frame: up to Week 48
Change from baseline in 24-hour Urinary Albumin-to-Creatinine Ratio (UACR) ;
Time frame: up to Week 48
Proportion of participants with 24-hour urinary protein quantification <0.5 g/d and <0.3 g/d ;
Time frame: up to Week 48
Proportion of participants with >30% and >50% reduction from baseline in 24-hour UPCR ;
Time frame: up to Week 48
Change from baseline in 24-hour urinary protein quantification ;
Time frame: up to Week 48
Change from baseline in estimated Glomerular Filtration Rate (eGFR) ;
Time frame: up to Week 48
Change from baseline in hematuria ;
Time frame: up to Week 48
Change from baseline in serum creatinine ;
Time frame: up to Week 48
Proportion of participants achieving clinical remission;
Time frame: up to Week 48
Annualized total eGFR slope from baseline ;
Time frame: up to Week 48
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Placebo
Proportion of participants meeting composite endpoints ;
Time frame: up to Week 48
Change from baseline in Kidney Disease Quality of Life Short Form (KDQoL-36) ;
Time frame: up to Week 48