Efficacy and safety of dapagliflozin in children with chronic kidney disease: A randomized clinical trial
- Conditions
- Health Condition 1: N182- Chronic kidney disease, stage 2 (mild)
- Registration Number
- CTRI/2024/03/063893
- Lead Sponsor
- Pankaj Hari
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 patient’s assent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method