Efficacy and safety of oral dapagliflozin in reducing proteinuria in children with proteinuric chronic kidney diseases.

All India Institute of Medical Sciences0 sites0 target enrollmentTBD

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: All India Institute of Medical Sciences
Status: Not Yet Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Investigators

Sponsor

All India Institute of Medical Sciences

Eligibility 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

•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

Outcomes

Primary Outcomes

Not specified

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EUCTR2016-003897-41-PLAstraZeneca AB4,500