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

NCT ID: NCT04531397

Last Updated: 2020-12-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-12-31

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.

Conditions

Proteinuria; Chronic Kidney Diseases

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACEI treatment

Drug: ACEI will be given once daily

Group Type: PLACEBO_COMPARATOR

ACEI treatment

Intervention Type: DRUG

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

Dapagliflozin+ACEI treatment

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

Group Type: EXPERIMENTAL

Dapagliflozin+ACEI treatment

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Control group; Treatment group

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:

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qian Shen, Profressor

Role: STUDY_DIRECTOR

Children's Hospital of Fudan University

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

EASOD.01

Identifier Type: -

Identifier Source: org_study_id