Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Dapaglilflozin: 10 mg OD, oral for 12 weeks
Control Intervention1: Not Applicable: Not Applicable
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage reduction in proteinuria from baselineTimepoint: at baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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: greater than or equal to 5% weight loss, hypovolemia (clinically or biochemically apparent), hypotension, hypoglycemia, urinary tract infection, genital candidiasis and bone fractures 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 | — |
Countries
India
Contacts
Public ContactDr Aditi Sinha
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed