NCT07354932招募中2 期
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
Guangdong Hengrui Pharmaceutical Co., Ltd2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2026年3月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究者
研究点 (2)
Loading locations...
相似试验
尚未招募
2 期
Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile DysfunctionErectile DysfunctionNCT07311330Beijing Inno Medicine Co., Ltd.40
进行中（未招募）
2 期
A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes MellitusNCT07321678Ascletis Pharma (China) Co., Limited100
招募中
2 期
Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes MellitusNCT07282743Sun Pharmaceutical Industries Limited285
已完成
1 期
Phase I Study of PollenVax in Patients With Mugwort Pollen-Induced Allergic RhinitisRhinitis AllergicNCT07317960Kazakh National Agrarian University30
招募中
2 期
A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)NCT07292714Mabwell (Shanghai) Bioscience Co., Ltd.360