A Study of SHR-2173 in Participants With Primary IgA Nephropathy

Official title

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-2173 Injection in Patients With Primary IgA Nephropathy

Overview

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

• Drug SHR-2173 injection
  SHR-2173 injection；High dose
• Drug SHR-2173 injection
  SHR-2173 injection；Medium dose
• Drug SHR-2173 injection
  SHR-2173 injection；Low dose
• Drug Placebo
  Placebo

Primary outcome measures

• Change from baseline in 24-hour Urine Protein-to-Creatinine Ratio (UPCR) at Week 24. [Time frame: Week 24.]

Secondary outcome measures (12)

• 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]
• 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]

Eligibility criteria

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

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1、Presence of any of the following medical histories or comorbidities:

• 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

2、Use of any of the following drugs/treatments or participation in a clinical study:

• 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);
• Receivied immunosuppressive therapy within 12 weeks before randomization;
• Received any investigational drug within 4 weeks before randomization or within the 5 half-lives of the trial drug, whichever was longer;
• Received a live / attenuated live vaccine administered within 4 weeks before randomization

3、History and examination related to infection:

• 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;
• Tuberculosis (TB) or occult TB infection (one of the following conditions) :

• Presence of active TB or clinical symptoms of active TB at screening;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07354932 · SHR-2173-205

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗