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

NCT04531397 | Withdrawn Phase 4

• 1 other identifier: EASOD.01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Proteinuria; Chronic Kidney Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The change in 24 hour proteinuria

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

  From baseline to week 12

Secondary Outcomes (6)

• The change in 24 hour proteinuria

  From baseline to week 24

• The change in albumin from baseline to week 24

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

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

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

• The change blood pressure from baseline to week 24

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

• The change in body weight from baseline to week 24

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

Study Arms (2)

ACEI treatment

PLACEBO COMPARATOR

Drug: ACEI will be given once daily

Drug: ACEI treatment

Dapagliflozin+ACEI treatment

EXPERIMENTAL

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

Drug: Dapagliflozin+ACEI treatment

Interventions

ACEI treatment 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

Also known as: Control group

ACEI treatment

Dapagliflozin+ACEI treatment 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.

Also known as: Treatment group

Dapagliflozin+ACEI treatment

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Proteinuria; Renal Insufficiency, Chronic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Qian Shen, Profressor

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 28, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 31, 2022
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)