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A study to find out how EMPAgliflozin is tolerated and if it helps children and adolescents with chronic KIDNEY disease (EMPA-KIDNEY Kids)

Chronic Kidney Disease | Children | Kidney | CKD

This study is being done to learn more about the tolerability, safety and efficacy of a medicine called EMPAgliflozin in children and adolescents with chronic kidney disease (CKD).

For the first 24 weeks, some children will receive empagliflozin, and others will receive a placebo (a pill with no medication in it). After the first 24 weeks, all children will have the option to receive empagliflozin for an additional 48 weeks. The entire study will last up to 80 weeks for each child.

The medication is a pill taken by mouth, twice a day.

Participants in the study will come to the Stollery Hospital approximately once a month for a year and a half.

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Participation Requirements

  • Sex:

    Female, Intersex, Any, Male

  • Eligible Ages:

    2 to 17

Participation Criteria

Inclusion Criteria:
• Age 2 to 17 years at screening Visit 1.
• Chronic Kidney Disease of any underlying cause
Exclusion Criteria:
• Confirmed type 1 diabetes mellitus.
• History of ketoacidosis within 8 weeks prior to study visit.
• Chronic dialysis or functioning kidney transplant or scheduled for transplantation.
• Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children <4 years of age.
• Presence of acute or active urinary tract infection (UTI) with signs or symptoms of an active UTI or therapeutic treatment for an active UTI within 14 days before study visit.
• Receiving combined angiotensin converting enzyme inhibitor (ACEi) and angiotensin receptor blocker (ARB) treatment.

Study Location

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Heather Mangan

[email protected]
780-248-5606
Study Sponsored By
University of Alberta
Participants Required
More Information
Study ID: Pro00155665