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Completed

NCT Number: NCT04534270

Efficacy and Safety of Dapagliflozin in Children With Proteinuria

The purpose of the study is to investigate the antiproteinuric effect of Dapagliflozin in children with proteinuria.

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Key information

Conditions

Proteinuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 6 years to 18 years;
  • Urinary protein excretion > 0.2g in a 24-hr urine collection;
  • eGFR≥60 ml/min/1.73m2;
  • No history of diabetes;
  • On stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) for > 1 month;

Exclusion criteria

  • Receiving immunosuppressive therapy within three months prior to enrolment.
  • Blood pressure less than 5th percentile of the same gender, age, and height -
  • Leukocyte and/or nitrite positive urinalysis that is untreated;
  • History of organ transplantation, cancer, liver disease;
  • Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit;
  • History of noncompliance to medical regimens or unwillingness to comply with the study protocol.

Treatment and study plan

Dapagliflozin

Drug

Dapagliflozin will be given 5mg per day (weight≤30kg) or 10mg per day (weight>30kg), for 12 weeks

Primary outcomes

  1. The change in 24-hr proteinuria after a 4 weeks treatment with dapagliflozin

    Time frame: From baseline to weeks 4

    Urine will be collected for 24 hours and total urinary protein will be detected

Secondary outcomes

  1. The change in 24-hr proteinuria after a 12 weeks treatment with dapagliflozin

    Time frame: From baseline to weeks 12

    Urine will be collected for 24 hours and total urinary protein will be detected

  2. The change in eGFR after a 12 weeks treatment with dapagliflozin

    Time frame: Measured at baseline, weeks 4, weeks 8, weeks 12

    eGFR are repeated measurement data and will be evaluated by Schwartz formula（k*height（cm)/creatinine(umol/L), k=36.5）

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

Efficacy and Safety of Dapagliflozin in Non-diabetic Children With Proteinuria

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 1, 2020
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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