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

Fudan University

Status and phase

Withdrawn

Phase 4

Conditions

Chronic Kidney Diseases

Proteinuria

Treatments

Drug: ACEI treatment

Drug: Dapagliflozin+ACEI treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04531397

EASOD.01

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

6 to 18 years old

Volunteers

No 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.