Primary IgA Nephropathy
Conditions
Brief 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.
Interventions
SHR-2173 injection；High dose
DRUGPlacebo
Placebo
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female participants aged 18 or older 2. Body weight ≥35 kg, BMI\<37.5 kg/m2 3. At screening, 24-hour urinary protein quantification ≥1 g/ day, or 24-hour UPCR≥0.7 g/g 4. eGFR≥30 mL/ minute /1.73 m2 at screening 5. 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
\- 1、Presence of any of the following medical histories or comorbidities: 1. 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; 2. A history of organ transplantation; 3. A history of splenectomy; 4. 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); 5. 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 2、Use of any of the following drugs/treatments or participation in a clinical study: 1. 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); 2. Receivied immunosuppressive therapy within 12 weeks before randomization; 3. Received any investigational drug within 4 weeks before randomization or within the 5 half-lives of the trial drug, whichever was longer; 4. Received a live / attenuated live vaccine administered within 4 weeks before randomization 3、History and examination related to infection: 1. A history of infection (viral, bacterial, fungal, parasitic infection) within 3 months prior to screening, resulting in hospitalization and/or parenteral systemic antimicrobial therapy; Or a history of infection requiring systemic antimicrobial therapy within 14 days before randomization; 2. Tuberculosis (TB) or occult TB infection (one of the following conditions) : 1. Presence of active TB or clinical symptoms of active TB at screening; 2. Signs of active TB on imaging examination within 3 months before screening 4、 General situation: 1\) Pregnant or lactating women; 2) Investigators determine that there are circumstances that affect the safety and efficacy evaluation of the investigational drug, or other circumstances not appropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in 24-hour Urine Protein-to-Creatinine Ratio (UPCR) at Week 24. | Week 24. |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in 24-hour UPCR ; | up to Week 48 |
| Change from baseline in 24-hour Urinary Albumin-to-Creatinine Ratio (UACR) ; | up to Week 48 |
| Proportion of participants with 24-hour urinary protein quantification <0.5 g/d and <0.3 g/d ; | up to Week 48 |
| Proportion of participants with >30% and >50% reduction from baseline in 24-hour UPCR ; | up to Week 48 |
| Change from baseline in 24-hour urinary protein quantification ; | up to Week 48 |
| Change from baseline in estimated Glomerular Filtration Rate (eGFR) ; | up to Week 48 |
| Change from baseline in hematuria ; | up to Week 48 |
| Change from baseline in serum creatinine ; | up to Week 48 |
| Proportion of participants achieving clinical remission; | up to Week 48 |
| Annualized total eGFR slope from baseline ; | up to Week 48 |
| Proportion of participants meeting composite endpoints ; | up to Week 48 |
| Change from baseline in Kidney Disease Quality of Life Short Form (KDQoL-36) ; | up to Week 48 |
Countries
China
Contacts
CONTACTKunming Li
Outcome results
None listed