A Prospective, Double-Blind, Multicentric, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Budesonide in Patients With Primary IgA Nephropathy(IgAN)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 试验地点
- 5
- 主要终点
- 1. Change in Urinary Protein Creatinine Ratio (uPCR) from
研究概览
简要总结
The protective effect of Budesonide on IgA Nephropathy is well researched. This study aims to evaluate the efficacy and safety of Budesonide in patients with primary IgA Nephropathy (IgAN). The primary objective is to assess the efficacy of budesonide in management of proteinuria and hematuria in subjects with primary IgA nephropathy. The secondary objective is to assess safety of budesonide in subjects with primary IgA nephropathy, based on adverse events, clinical laboratory results, and vital signs assessments. The study is designed as a Prospective, Double-Blind, Multicentric, Interventional, Randomized, Placebo-controlled, Investigator-initiated study. The study population consist of patients in the age group of ≥12 years diagnosed with primary IgA nephropathy confirmed by the most recent renal biopsy (within the past 10 years).
Subjects satisfying all eligibility criteria will be enrolled from 4-5 study sites after obtaining written informed consent (or assent, as applicable). After baseline assessment, subjects will berandomized 1:1 to be administered either 9 mg budesonide or placebo. All adverse events will be recorded. Data collected at baseline and follow-up visits will be analyzed.
The study visit will be as per the following schedule:
Visit 1 (Day -7): Informed consent and Screening
Visit 2 (Day 0): Randomization, baseline assessment, and treatment initiation
Visit 3 (Day 90 ± 7 days): Follow-up visit
Visit 4 (Day 180 ± 7 days): Follow-up visit
Visit 5 (Day 270 ± 7 days): Follow-up visit
Visit 6 (Day 360 ± 7 days): End of treatment and end-of-study visit
Unscheduled visit: As required (during study participation)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Female or male aged greater than equal to 12 years
- •Primary IgA nephropathy confirmed by the most recent renal biopsy (within the past 10 years)
- •Estimated Glomerular Filtration Rate (eGFR using CKD-EPI equation) greater than 30 mL by min per 1.73 m2 despite optimized renin-angiotensin system blockade for a minimum of 1 month and a maximum of 6 months
- •Urinary Protein Creatinine Ratio (uPCR) greater than equal to 0.8 g by g or urinary total protein greater than equal to 1 g by d
- •Willingness to provide written informed consent (or assent, as applicable).
排除标准
- •1.Secondary IgAN (for example, IgAN associated with disorders like viral infections, autoimmune disorders, or malignancy) 2.Systemic diseases that may cause mesangial IgA deposition 3.Non-IgAN glomerulonephritis 4.History of kidney transplantation 5.Nephrotic syndrome or a rapidly progressive clinical course which would make the patient, in the opinion of the Investigator, unsuitable for the study 6.Severe histological lesions of activity/chronicity characterized by the following: endocapillary hypercellularity in >50% of examined glomeruli, crescents in >30% of examined glomeruli, presence of fibrinoid necrosis, global glomerulosclerosis in over 50% of examined glomeruli
- •History of or current acute or chronic diseases including hepatitis, tuberculosis, or human immunodeficiency virus (HIV), chronic urinary tract infections, or liver cirrhosis 8.Known diagnosis of unregulated Type I or Type II diabetes mellitus (glycated hemoglobin >8%), gastrointestinal disorders, active infections, arrhythmia or cardiovascular conditions, judged to be clinically significant as per the Investigator 9.Inadequately controlled blood pressure (i.e., systolic blood pressure/diastolic blood pressure ≥140/90 mm Hg) 10.History of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator 11.Presence of medium- or high-risk osteoporosis 12.History of glaucoma, cataract, or single-eye cataract surgery 13.Treatment with potent inhibitors of cytochrome P450 3A4(CYP3A4) 14.Life expectancy <5 years according to the Investigator 15.Pregnant or breastfeeding women, or women of child-bearing potential not in agreement to use adequate birth control methods throughout the study 16.Known allergy or hypersensitivity to the components of the study medication 17.Participation in another clinical trial within past 30 days 18.Planned participation in any other trial during the entire duration of the study 19.Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests 20.Any other condition(s) which would make the patient, in the opinion of the Investigator, unsuitable for the study.
结局指标
主要结局
1. Change in Urinary Protein Creatinine Ratio (uPCR) from
时间窗: 3 months, 6 months, 9 months, 12 months
baseline to 3, 6, 9, and 12 months
时间窗: 3 months, 6 months, 9 months, 12 months
2. Change in Urinary Albumin Creatinine Ratio (uACR) from
时间窗: 3 months, 6 months, 9 months, 12 months
3. Change in estimated Glomerular Filtration Rate (eGFR; calculated using the CKD-EPI formula) from baseline to 3, 6,9, and 12 months
时间窗: 3 months, 6 months, 9 months, 12 months
4. Change in hematuria or proportion of subjects with hematuria from baseline to 3, 6, 9, and 12 months
时间窗: 3 months, 6 months, 9 months, 12 months
次要结局
- 1. Clinical laboratory results for hemogram, HbA1C, and(kidney function test at baseline, and at the end of 6 and 12 months of treatment)
- Proportion of subjects with adverse events and serious(adverse events upon treatment with budesonide)
研究者
Dr Narayan Prasad
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow