Effectiveness and safety of oral dapagliflozin in reducing urinary leakage of protein in children with reduced kidney function.
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecified
- Registration Number
- CTRI/2022/04/042032
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Chronic kidney disease (CKD) stage 1 or 2 (eGFR greater than 60 mL/minute per 1.73 m2) 2)Nephrotic range proteinuria on two consecutive evaluations (greater than 1 g/m2 daily; greater than 40 mg/m2 /hr ) 3) On weight-appropriate dose of either an ACE-inhibitor or aldosterone receptor blocker for greater than or equal to 4 weeks, with dose not expected to change over the next 12 weeks 4) If on immunosuppression, doses not expected to change over next 12 weeks
1) Blood pressure below 5th percentile for age, sex and height percentile
2) Clinical or biochemical feature(s) of hypovolemia
3) Body mass index less than -2 standard deviation scores for age and sex
4) Diabetes mellitus or hyperglycemia
5) Hyponatremia (serum sodium less than 135 mEq/L)
6) Serum albumin less than 2 g/dL
7) Hepatic transaminases (AST/ALT) greater than 3 times upper limit of normal
8) Pancreatic injury or pancreatitis within the last 6 months
9) Known inflammatory bowel disease; major gastrointestinal tract surgery; gastrointestinal ulcers; and/or gastrointestinal or rectal bleeding in last 6 months
10) History of noncompliance to medical regimens or unwillingness to comply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage reduction in proteinuria from baselineTimepoint: at baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method Absolute and percentage reduction in albuminuria (urine albumin/creatinine ratio)Timepoint: 12 weeks;Absolute reduction in proteinuria (g/m2) between baselineTimepoint: 12 weeks;Proportion of patients with clinically significant adverse effects, including: <br/ ><br> greater than or equal to 5% weight loss, hypovolemia (clinically or biochemically apparent), hypotension, <br/ ><br> hypoglycemia, urinary tract infection, genital candidiasis and bone fractures <br/ ><br>Timepoint: 12 weeks;Proportion of patients with reduction of proteinuria by greater than 20 percentage from baseline, and/or to non-nephrotic rangeTimepoint: 12 weeks;The percentage change from baseline in: urine output, blood pressure, estimated GFR, weight, fasting blood sugar, serum albumin and total cholesterolTimepoint: 12 weeks