A Study of SHR-2173 in Participants With Primary IgA Nephropathy (NCT07354932) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of SHR-2173 in Participants With Primary IgA Nephropathy
China84 participantsStarted 2026-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male and female participants aged 18 or older
✓. Body weight ≥35 kg, BMI\<37.5 kg/m2
✓. At screening, 24-hour urinary protein quantification ≥1 g/ day, or 24-hour UPCR≥0.7 g/g
✓. eGFR≥30 mL/ minute /1.73 m2 at screening
✓. Female subjects with fertility or male participants whose partners are women of childbearing age must avoid donating sperm/eggs from the date of signing the ICF until 12 weeks after the last study medication, and agree to take contraceptive measures as specified in the protocol
Exclusion criteria
✕. Renal pathology consistent with IgAN, but secondary factors could not be excluded by investigator evaluation, including but not limited to: secondary to systemic diseases, infections, autoimmune diseases or tumors;
✕. A history of organ transplantation;
✕. A history of splenectomy;
✕. Presence or history of malignancy within 5 years before screening (note: skin squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ with complete resection and no evidence of recurrence are excluded);
✕. A history of anaphylaxis such as generalized urticaria, angioedema, or anaphylaxis, or a known history of allergy to the study drug or any component of the study drug
✕. Received systemic glucocorticoid therapy (including gut-targeted budesonide, etc.) within 12 weeks before randomization (Note: except those not used within 4 weeks before randomization and received prednisone ≤0.5mg/kg or equivalent glucocorticoid for non-IgAN disease within 52 weeks before randomization, with no more than 3 courses (each course ≤2 weeks);
What they're measuring
1
Change from baseline in 24-hour Urine Protein-to-Creatinine Ratio (UPCR) at Week 24.