Health Condition 1: N182- Chronic kidney disease, stage 2 (mild)
Conditions
Interventions
Intervention1: Dapagliflozin: Therapy with dapagliflozin (10 mg) administered once per day for 24 weeks. Dapagliflozin will be given in tablet formulation A strip containing 14 tablets containing dapa
Sponsors
Pankaj Hari
Eligibility
Inclusion criteria
Inclusion criteria: 1. Chronic kidney disease stage G1-3b (eGFR more than 45 ml per min per 1.73 m2) 2. Age group 6 to 18 years 3. On optimal dose (6 mg per m2 per day) or maximum tolerable dose of ramipril for at least 8 weeks •Proteinuria more than 500 mg per m2 per day •Off immunosuppression or on stable immunosuppression for last 6 months which is unlikely to change over next 6 months •Written informed parental consent and patientâ??s assent
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus or hyperglycemia 2. CKD secondary to ADPKD, ARPKD 3. History of organ transplantation 4. Blood pressure below 5th percentile for age, sex, and height percentile 5. Body mass index less than -3 SDS 6. Clinical or biochemical feature (s) of hypovolemia 7. Congestive heart failure 8. Active systemic infection or urinary tract infection 9. Evidence of pancreatitis within the last 6 months 10. Malabsorptive states (such as inflammatory bowel disease; major gastrointestinal tract surgery; celiac disease) 11. History of noncompliance to medical regimens or unwillingness to comply 12. Inability to take oral medications 13. Hepatic transaminases (AST or ALT) more than 2 times upper limit of normal 14. Hyponatremia (serum sodium less than 135 mEq or L) 15. Serum albumin less than 2 g or dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of dapagliflozin versus placebo in reducing proteinuria in children aged 6 to 18 years with CKD who are on optimal ramipril therapy.Timepoint: At end 24 weeks following randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in estimated glomerular filtration rate from baseline to end of therapy at 24 weeksTimepoint: At end of 24 weeks following randomization;Absolute and percentage reduction in albuminuria (urine albumin to creatinine ratio)Timepoint: At end of 24 weeks following randomization;Proportion of patients with reduction of proteinuria by more than 20% from baselineTimepoint: At end of 24 weeks following randomization;Proportion of patients with proteinuria less than 1.5 gm per gm of creatinineTimepoint: At end of 24 weeks following randomization;The percentage change from baseline to 24 weeks, in: urine output, blood pressure, weight, fasting blood sugar, serum albumin & total cholesterolTimepoint: At end 24 weeks following randomization;Proportion of patients with clinically significant adverse events, including: Significant weight loss (more than equal to 5%), hypovolemia, hypotension, hypoglycemia, diabetic ketoacidosis, urinary tract infection, genital candidiasis, & bone fractures Timepoint: At end 24 weeks following randomization | — |
Countries
India
Contacts
Public ContactPankaj Hari
AIIMS, New Delhi
Outcome results
None listed