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临床试验/CTRI/2022/04/042214
CTRI/2022/04/042214尚未招募不适用

Utility of Serum Galactose Deficient for Ig A nephropathy: Prospective study from A Tertiary care center in South India"

MRU1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月5日最近更新:

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)

研究者

发起方
MRU
申办方类型
Government funding agency

研究点 (1)

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