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

Primary Purpose

Proteinuria, Chronic Kidney Diseases

Status

Withdrawn

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

ACEI treatment

Dapagliflozin+ACEI treatment

About this trial

This is an interventional treatment trial for Proteinuria focused on measuring Angiotensin Converting Enzyme Inhibitors, Sodium-glucose co-transporter 2 inhibitors, Dapagliflozin

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

ACEI treatment

Dapagliflozin+ACEI treatment

Arm Description

Drug: ACEI will be given once daily

Drug: ACEI, will be given once daily Drug: Dapagliflozin, will be given once daily

Outcomes

Primary Outcome Measures

The change in 24 hour proteinuria

Urine will be collected for 24 hours and total urinary albumin excretion will be measured

Secondary Outcome Measures

The change in 24 hour proteinuria

Urine will be collected for 24 hours and total urinary albumin excretion will be measured

The change in albumin from baseline to week 24

Serum albumin levels are repeated measurement data

The change in eGFR (estimated glomerular filtration rate) from baseline to week 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

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

Body weight are repeated measurement data and will be measured in the morning

The number of hypoglycemia episodes during the treatment

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.

Full Information

NCT ID

NCT04531397

First Posted

August 26, 2020

Last Updated

December 24, 2020

Sponsor

Children's Hospital of Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04531397

Brief Title

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

Official Title

Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease : a Prospective, Randomized, Placebo-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Withdrawn

Why Stopped

lack of funding

Study Start Date

January 1, 2021 (Anticipated)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proteinuria, Chronic Kidney Diseases

Keywords

Angiotensin Converting Enzyme Inhibitors, Sodium-glucose co-transporter 2 inhibitors, Dapagliflozin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACEI treatment

Arm Type

Placebo Comparator

Arm Description

Drug: ACEI will be given once daily

Arm Title

Dapagliflozin+ACEI treatment

Arm Type

Experimental

Arm Description

Drug: ACEI, will be given once daily Drug: Dapagliflozin, will be given once daily

Intervention Type

Drug

Intervention Name(s)

ACEI treatment

Other Intervention Name(s)

Control group

Intervention Description

ACEI, will be given once daily based on body weight (0.2mg/kg/d-0.6mg/kg/d，max 20mg/d), for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin+ACEI treatment

Other Intervention Name(s)

Treatment group

Intervention Description

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.

Primary Outcome Measure Information:

Title

The change in 24 hour proteinuria

Description

Urine will be collected for 24 hours and total urinary albumin excretion will be measured

Time Frame

From baseline to week 12

Secondary Outcome Measure Information:

Title

The change in 24 hour proteinuria

Description

Urine will be collected for 24 hours and total urinary albumin excretion will be measured

Time Frame

From baseline to week 24

Title

The change in albumin from baseline to week 24

Description

Serum albumin levels are repeated measurement data

Time Frame

Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24

Title

The change in eGFR (estimated glomerular filtration rate) from baseline to week 24

Description

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

Time Frame

Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24

Title

The change blood pressure from baseline to week 24

Description

Blood pressure including systolic blood pressure (SBP) and diastolic blood pressure (DBP) are repeated measurement data

Time Frame

Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24

Title

The change in body weight from baseline to week 24

Description

Body weight are repeated measurement data and will be measured in the morning

Time Frame

Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24

Title

The number of hypoglycemia episodes during the treatment

Description

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.

Time Frame

From baseline to week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: History of active inflammatory bowel disease within the last six months; Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months; 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qian Shen, Profressor

Organizational Affiliation

Children's Hospital of Fudan University

Official's Role

Study Director

Facility Information:

Facility Name

Children's Hospital of Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201102

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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