Replication of the NefIgArd Trial of Effectiveness and Safety of a Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Urinary Protein Levels from Baseline at 9 months Primary endpoint
研究概览
简要总结
This replication of the NefIgArd trial of TRF-budesonide aims to use real-world data to evaluate the efficiency and safety of TRF-budesonide in the treatment of IgA nephropathy, from completing real-world research to providing real-world evidence.
详细描述
Currently, TRF-budesonide are the first specific treatment for IgA nephropathy that targets intestinal mucosal immunity. Results from part A of the Phase III clinical trial (NCT03643965) show that compared to the placebo group, the TRF-budesonide group significantly reduced proteinuria and hematuria, stabilized renal function, and lowered circulating Gd-IgA1 levels at 12 months. However, further real-world studies are needed to verify the efficiency and safety of this treatment for IgA nephropathy. Therefore, this replication trial of the part A of the Phase III clinical trial NefIgArd and evaluates the efficiency and safety of TRF-budesonide in treating IgA nephropathy based on existing observational data, aiming to complete real-world research to provide real-world evidence that can guide clinical practice for IgA nephropathy treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 or female patients aged ≥18 years;
- •Primary IgA nephropathy confirmed by renal biopsy;
- •Stable use of RAS blockers;
- •24-hour urine albumin quantitation ≥1g/day, or urine protein/creatinine ratio ≥0.8g/g (≥90 mg/mmol);
- •eGFR ≥30 mL/min/1.73m².
排除标准
- •Systemic diseases that may cause interstitial IgA deposition, including but not limited to anaphylactoid purpura, systemic lupus erythematosus, herpetic dermatitis, and ankylosing spondylitis;
- •Patients who have received kidney transplants;
- •Those with other glomerular diseases (such as C3 glomerular disease or diabetic nephropathy) and nephrotic syndrome;
- •Patients with acute, chronic, or latent infectious diseases, including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections;
- •Patients with cirrhosis or severe liver function impairment, as assessed by the investigator;
- •Patients diagnosed with poorly controlled type 1 or type 2 diabetes;
- •Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or arrhythmia as assessed by the investigator;
- •Patients with poorly controlled blood pressure with systolic or diastolic blood pressure ≥140mmHg or 90mmHg. At least one blood pressure measurement should be in the above range (based on up to three measurements, 1 minute apart, taken after resting in the supine position for at least 5 minutes);
- •Patients diagnosed with malignancy within the last 5 years, with the exception of treated basal cell carcinoma of the skin, curably resected squamous cell carcinoma of the skin, polyps of the colon, or carcinoma in situ of the cervix;
- •Patients with osteoporosis who are known to be at moderate or high risk. Chinese patients are defined according to the Asian Osteoporosis Self-Assessment Tool (OSTA) Index;
- •Patients with known glaucoma, known history of cataract and/or cataract surgery that may interfere with study drug action or release (such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea);
- •Patients who are allergic to budesonide or any component of the investigational drug formulation;
- •Patients who have previously had a severe adverse reaction to steroids;
- •Patients with psychotic symptoms;
- •Have received any systemic glucocorticoid therapy within 3 months prior to medication;
- •Received immunosuppressants or biologics within 3 months prior to medication;
- •Patients taking potent inhibitors of the cytochrome P450 3A4 enzyme (CYP3A4);
- •Current or former (within the last 2 years) alcohol or drug abuse;
- •Patients who are unwilling or unable to meet program requirements;
- •Life expectancy <5 years;
- •Women who are pregnant, nursing, or unwilling to use contraception during treatment.
研究组 & 干预措施
Treat
TRF-budesonide enteric-coated capsule（TARPEYO）
干预措施: TARPEYO 4 MG Delayed Release Oral Capsule (Drug)
Control
RAS blocker
干预措施: RAS inhibitor (Drug)
结局指标
主要结局
Change in Urinary Protein Levels from Baseline at 9 months Primary endpoint
时间窗: 9 months
Assessment of the change in 24-hour urine protein levels from baseline after 9 months of follow-up.
Change in eGFR from Baseline at 9 Months
时间窗: 9 months
Measurement of the change in estimated glomerular filtration rate (eGFR) from baseline after 9 months of follow-up.
次要结局
- Change in 24-Hour Urine Protein Levels Compared to Baseline at 12 Months(12 months)
- Change in eGFR Compared to Baseline at 12 Months(12 months)
- Incidence Rate of Adverse Events(12 months)