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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Change from baseline in 24-hour UPCR ; [Срок оценки: up to Week 48]
• Change from baseline in 24-hour Urinary Albumin-to-Creatinine Ratio (UACR) ; [Срок оценки: up to Week 48]
• Proportion of participants with 24-hour urinary protein quantification <0.5 g/d and <0.3 g/d ; [Срок оценки: up to Week 48]
• Proportion of participants with >30% and >50% reduction from baseline in 24-hour UPCR ; [Срок оценки: up to Week 48]
• Change from baseline in 24-hour urinary protein quantification ; [Срок оценки: up to Week 48]
• Change from baseline in estimated Glomerular Filtration Rate (eGFR) ; [Срок оценки: up to Week 48]
• Change from baseline in hematuria ; [Срок оценки: up to Week 48]
• Change from baseline in serum creatinine ; [Срок оценки: up to Week 48]
• Proportion of participants achieving clinical remission; [Срок оценки: up to Week 48]
• Annualized total eGFR slope from baseline ; [Срок оценки: up to Week 48]
• Proportion of participants meeting composite endpoints ; [Срок оценки: up to Week 48]
• Change from baseline in Kidney Disease Quality of Life Short Form (KDQoL-36) ; [Срок оценки: up to Week 48]

Критерии участия

Критерии включения

• 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

Критерии исключения

\-

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

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

Идентификаторы

NCT: NCT07354932 · SHR-2173-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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