NCT06676007招募中不适用
A Multicenter Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
Sichuan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年10月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The changes in proteinuria levels
研究概览
简要总结
To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Target patients aged 18-75, including those aged 18 and 75
- •Primary IgA nephropathy diagnosed by renal biopsy within 3 months
- •eGFR≥30ml/min/1.73m2
- •24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g
- •Sign informed consent
排除标准
- •Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis
- •Patients who have received kidney transplantation or dialysis
- •Patients with other glomerular diseases (such as C3 glomerular disease and/or diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria>3.5 g/d, serum albumin<3.0 g/dl, with or without edema)
- •Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections
- •Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c>8%)
- •Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically significant arrhythmias
- •Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg)
- •Patients diagnosed with malignant tumors within the past 5 years
- •Patients with known glaucoma, known cataracts, and/or a history of cataract surgery
- •Gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea
- •Patients with severe adverse reactions to steroids in the past, including psychiatric symptoms
- •Patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment
- •Patients who have received any systemic GCS treatment within the past 3 months prior to enrollment
- •Patients taking potent cytochrome P450 3A4 inhibitors (CYP3A4)
- •Current or previous (within the past 2 years) alcoholism or drug abuse;
- •Expected lifespan<5 years
- •During the study treatment period and 3-month follow-up period, women who are pregnant, breastfeeding, or unwilling to use highly effective contraception (contraception is only required for women with fertility potential)
- •Researchers believe that patients who are not suitable for treatment with Nefecon
结局指标
主要结局
The changes in proteinuria levels
时间窗: about 12 months
To evaluate the changes in proteinuria levels of the target patient in the 12th month compared to baseline
Number of Participants With clinical significant Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
时间窗: about 12 months
Safety event
次要结局
- Evaluate the changes in eGFR of target patients at the 12th month compared to baseline(about 12 months)
- Evaluate the changes in microscopic hematuria of the target patient at the 12th month compared to baseline(about 12 months)
- Assess the incidence of composite renal endpoint events (eGFR decreased by 40% from baseline or ESKD) in target patients(about 12 months)
- Assess the incidence of ESKD (eGFR<15ml/min/1.73m2) in target patients at the 12th month(about 12 months)
- Evaluate the proportion of target patients with a 40% decrease in eGFR compared to baseline at the 12th month(about 12 months)
- Evaluate the proportion of target patients whose average urinary protein level decreased by 50% from baseline in the 12th month(about 12 months)
- Evaluate the changes in serum and urine proteomics and metabolomics of the target patient in the 12th month(about 12 months)
研究者
Guisen Li
Director of Nephrology Department
Sichuan Provincial People's Hospital
研究点 (1)
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