Utility of Serum Galactose Deficient for Ig A nephropathy: Prospective study from A Tertiary care center in South India"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- MRU
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- a)50 % fall from initial eGFR
研究概览
简要总结
This is a single center, prospective, observational study to to assess utility of galactose deficient IgA1 as a diagnostic marker for IgA nephropathy and to correlate the levels of galactose deficient IgA1 with severity of progression. We will be recruiting 50 patients ( age 2-80 years) with biopsy proven Ig A nephropathy not yet initiated on any immunosuppressive therapy. Demographic, clinical and laboratory (Including but not limited to serum creatinine, serum albumin and serum cholesterol and urinary protein creatinine ratio) will be recorded. Estimated glomerular filtration rate(eGFR) will be calculated using the 4 variable Modification of Diet in Renal Disease (MDRD) formula or CKD- EPI formula for adults and the revised Schwartz formula for those who were <18 years of age. Renal biopsy(LM,IF and EM) findings will be noted. Gd-IgA1 level in serum will be measured by solid phase sandwich enzyme immunoassay kit (IBL international GmBH, Germany) following the manufacturer’s instructions. Patients will be initiated on guideline based therapy and followed up with investigations once in 3-4 months for a period of 24 months. Similarly, controls will be taken from non Ig A gloemerular diseases such as memebranous nephropthay and FSGS. Study end points are defined as 1. more than 50 % fall from initial eGFR 2. ESRD – either estimated creatinine clearance <15 ml/mt or initiation of renal replacement therapy(RRT) and 3. death
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with biopsyy proven primary IgA nephropathy.
排除标准
- •(1)Who do not give informed consent.
- •(2)Has history of immunosuppression use before sample collection.
- •(3)Has secondary causes of IgAN like chronic liver disease (4)Henoch-Schonlein purpura (5)a coexisting systemic disease features like diabetic nephropathy (6)inadequate kidney biopsy.
结局指标
主要结局
a)50 % fall from initial eGFR
时间窗: 4 months
b)ESRD – either estimated creatinine clearance 15 ml/mt or initiation of renal replacement therapy (PD/HD)
时间窗: 4 months
c)Death
时间窗: 4 months
次要结局
- Mortality(2 years)
- Infections during the clinical course of the disease(2 years)
- Cardiovascular complications during the study period(2 years)
- Hospitalizations(2 years)
