A Study of SHR-2173 in Participants With Primary IgA Nephropathy
ConditionPrimary IgA Nephropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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);
Trial design
Treatments tested in this trial
- SHR-2173 injection
- SHR-2173 injection
- SHR-2173 injection
- Placebo
Treatment groups
84 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov