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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Recruitment Status : Withdrawn (lack of funding)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

Tracking Information
First Submitted Date  ICMJE August 26, 2020
First Posted Date  ICMJE August 28, 2020
Last Update Posted Date December 29, 2020
Estimated Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
The change in 24 hour proteinuria [ Time Frame: From baseline to week 12 ]
Urine was collected for 24 hours and total urinary albumin excretion were measured
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
  • 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 were measured
  • 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
  • The change in eGFR 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 (k=36.5), and eGFR are repeated measurement data
  • 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
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease
Official Title  ICMJE Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease : a Prospective, Randomized, Placebo-controlled Trial
Brief Summary We aim to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Proteinuria
  • Chronic Kidney Diseases
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: ACEI treatment
    Drug: ACEI will be given once daily
    Intervention: Drug: ACEI treatment
  • Experimental: Dapagliflozin+ACEI treatment
    Drug: ACEI, will be given once daily Drug: Dapagliflozin, will be given once daily
    Intervention: Drug: Dapagliflozin+ACEI treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 24, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2020)
50
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04531397
Other Study ID Numbers  ICMJE EASOD.01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Children's Hospital of Fudan University
Study Sponsor  ICMJE Children's Hospital of Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Qian Shen, Profressor Children's Hospital of Fudan University
PRS Account Children's Hospital of Fudan University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP