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Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT04531397
Recruitment Status : Withdrawn (lack of funding)
First Posted : August 28, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Brief Summary:
We aim to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria.

Condition or disease Intervention/treatment Phase
Proteinuria Chronic Kidney Diseases Drug: ACEI treatment Drug: Dapagliflozin+ACEI treatment Phase 4

Detailed Description:
Blockers of renin angiotensin aldosterone system (RAAS) such as angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARBs) are considered the standard of care in treatment of Proteinuric Chronic Kidney Disease. However, these agents lead to incomplete renal protection. The purpose of the study is to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria. In this study, participants were randomly assigned (1:1) to receive ACEI+Dapagliflozin (5mg or 10mg, based on body weight) or ACEI only once daily for 24 weeks. Prespecified outcomes includes changes in 24-hr proteinuria, albumin, eGFR (estimated glomerular filtration rate), blood pressure, body weight and so on.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease : a Prospective, Randomized, Placebo-controlled Trial
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Placebo Comparator: ACEI treatment
Drug: ACEI will be given once daily
Drug: ACEI treatment
ACEI, will be given once daily based on body weight (0.2mg/kg/d-0.6mg/kg/d,max 20mg/d), for 24 weeks
Other Name: Control group

Experimental: Dapagliflozin+ACEI treatment
Drug: ACEI, will be given once daily Drug: Dapagliflozin, will be given once daily
Drug: Dapagliflozin+ACEI treatment
Dapagliflozin will be given 10 mg/day (weight>30kg) or 5mg/day (weight≤30kg), for 24 weeks ACEI, will be given based on body weight (max 20mg/d), for 24 weeks.
Other Name: Treatment group




Primary Outcome Measures :
  1. The change in 24 hour proteinuria [ Time Frame: From baseline to week 12 ]
    Urine will be collected for 24 hours and total urinary albumin excretion will be measured


Secondary Outcome Measures :
  1. The change in 24 hour proteinuria [ Time Frame: From baseline to week 24 ]
    Urine will be collected for 24 hours and total urinary albumin excretion will be measured

  2. The change in albumin from baseline to week 24 [ Time Frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24 ]
    Serum albumin levels are repeated measurement data

  3. The change in eGFR (estimated glomerular filtration rate) from baseline to week 24 [ Time Frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24 ]
    eGFR will be evaluated using Schwartz formula (eGFR=k*height(cm)/serum creatinine(umol/L)), k=36.5), and eGFR are repeated measurement data

  4. The change blood pressure from baseline to week 24 [ Time Frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24 ]
    Blood pressure including systolic blood pressure (SBP) and diastolic blood pressure (DBP) are repeated measurement data

  5. The change in body weight from baseline to week 24 [ Time Frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24 ]
    Body weight are repeated measurement data and will be measured in the morning

  6. The number of hypoglycemia episodes during the treatment [ Time Frame: From baseline to week 24 ]
    Patients will be asked to measure fasting blood glucose every morning and record the data by their parents during the treatment period. Hypoglycemia is defined as glucose level less than 3.9mmol/L.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6 years to 18 years;
  • Urinary protein excretion > 200 mg in a 24-hr urine collection;
  • Without any immunosuppressant medications such as corticosteroids, CNIs and so on;
  • Estimated GFR ≥ 60 ml/min/1.73m2(estimated with Schwartz formula);
  • No history of diabetes;
  • On stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) for > 1 month;
  • Willing to sign informed consent.

Exclusion Criteria:

  • Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis;
  • Blood pressure less than 5th percentile of the same gender, age, and height;
  • Uncontrolled urinary tract infection at screening;
  • At risk for dehydration or volume depletion;
  • Evidence of hepatic disease: an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) two times the upper limit of normal
  • History of organ transplantation, cancer, liver disease;
  • Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:

    1. History of active inflammatory bowel disease within the last six months;
    2. Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
    3. Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
    4. Pancreatic injury or pancreatitis within the last six months;
  • Participation in another therapeutic trial with an investigational drug within 30 days prior to informed consent;
  • History of noncompliance to medical regimens or unwillingness to comply with the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531397


Locations
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China, Shanghai
Children's Hospital of Fudan University
Shanghai, Shanghai, China, 201102
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Director: Qian Shen, Profressor Children's Hospital of Fudan University
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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04531397    
Other Study ID Numbers: EASOD.01
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Fudan University:
Angiotensin Converting Enzyme Inhibitors
Sodium-glucose co-transporter 2 inhibitors
Dapagliflozin
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Proteinuria
Urologic Diseases
Renal Insufficiency
Urination Disorders
Urological Manifestations
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Angiotensin-Converting Enzyme Inhibitors
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors