Effectiveness and Safety of Budesonide in Primary IgA Nephropathy (IgAN) patients
- Conditions
- Health Condition 1: N08- Glomerular disorders in diseases classified elsewhere
- Registration Number
- CTRI/2024/02/062222
- Lead Sponsor
- Fourrts (India) Laboratories Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in Urinary Protein Creatinine Ratio (uPCR) from <br/ ><br>baseline to 3, 6, 9, and 12 months <br/ ><br>2. Change in Urinary Albumin Creatinine Ratio (uACR) from <br/ ><br>baseline to 3, 6, 9, and 12 months <br/ ><br>3. Change in estimated Glomerular Filtration Rate (eGFR; calculated using the CKD-EPI formula) from baseline to 3, 6,9, and 12 months <br/ ><br>4. Change in hematuria or proportion of subjects with hematuria from baseline to 3, 6, 9, and 12 monthsTimepoint: 3 months, 6 months, 9 months, 12 months
- Secondary Outcome Measures
Name Time Method 1. Clinical laboratory results for hemogram, HbA1C, and <br/ ><br>kidney function test at baseline, and at the end of 6 and 12 months of treatment <br/ ><br>2. Results for vital signs (pulse rate, respiratory rate, blood <br/ ><br>pressure, and body temperature) at baseline, and at the end of 6 and 12 months of treatmentTimepoint: 6months, 12 months <br/ ><br>;Proportion of subjects with adverse events and serious <br/ ><br>adverse events upon treatment with budesonideTimepoint: Baseline, Month 3, Month 6, Month 9, Month 12