CTRI/2024/02/062222尚未招募Unknown
A Prospective, Double-Blind, Multicentric, Randomized,Placebo-controlled Clinical Trial to Evaluate the Efficacy andSafety of Budesonide in Patients With Primary IgA Nephropathy(IgAN) - NI
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Female or male aged greater than equal to 12 years
- •2. Primary IgA nephropathy confirmed by the most recent renal biopsy (within the past 10 years)
- •3. 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
- •4. 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
- •5. 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
- •7. 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
研究者
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