Actively Recruiting
A Study of SHR-2173 in Participants With Primary IgA Nephropathy
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2026-05-13
84
Participants Needed
2
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SHR-2173 in Participants With Primary IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 or older
- Body weight at least 35 kg and BMI less than 37.5 kg/m2
- At screening, 24-hour urinary protein quantification of at least 1 g/day, or 24-hour UPCR of 0.7 g/g or more
- eGFR of 30 mL/min/1.73 m2 or higher at screening
- Female participants who can become pregnant and male participants with partners of childbearing potential must agree to use contraception and avoid sperm/egg donation from consent until 12 weeks after last study medication
You will not qualify if you...
- Renal pathology consistent with IgAN but with possible secondary factors such as systemic diseases, infections, autoimmune diseases, or tumors
- History of organ transplantation
- History of splenectomy
- History or presence of malignancy within 5 years before screening (except certain skin or cervical cancers fully treated with no recurrence)
- History of severe allergic reactions or known allergy to study drug or components
- Use of systemic glucocorticoid therapy within 12 weeks before randomization (with specified exceptions)
- Use of immunosuppressive therapy within 12 weeks before randomization
- Use of any investigational drug within 4 weeks before randomization or within 5 half-lives of the trial drug
- Receipt of live or attenuated live vaccine within 4 weeks before randomization
- History of infection requiring hospitalization or parenteral systemic antimicrobial therapy within 3 months before screening or systemic antimicrobial therapy within 14 days before randomization
- Active or occult tuberculosis at screening
- Pregnant or lactating women
- Other conditions deemed by investigators to affect safety or study evaluation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Actively Recruiting
2
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
K
Kunming Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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