SGLT 2 InhibitorsNCT07204743
Efficacy and Safety of Dapagliflozin in Children With Proteinuria
A study testing Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy in people with SGLT 2 Inhibitors and Pediatric Kidney Disease, run by Al-Quds University at 1 site in Palestinian Territories.
Trial summary
This interventional study investigates the efficacy of dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in pediatric patients with renal disease. The primary outcomes include changes in 24-hour proteinuria indexed to body surface area (mg/m²/day) and glomerular filtration rate (GFR) before and after… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- SGLT 2 Inhibitors, Pediatric Kidney Disease, Proteinuric Diseases
- What is being tested?
- Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 15 Aug 2025to Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients aged 4-18 years
- Persistent proteinuria > 500 mg/day despite standard therapy.
- Stable renal function (eGFR ≥ 30 mL/min/1.73 m²).
- Ability to comply with follow-up visits and study procedures.
- Written informed consent obtained from parents or legal guardians, and assent from the patient when appropriate.
Who cannot join
- Known hypersensitivity or contraindication to dapagliflozin or other SGLT2 inhibitors.
- Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or end-stage renal disease requiring dialysis.
- Active urinary tract infection, severe dehydration, or hypotension.
- Participation in another clinical trial within the last 30 days.
- Any comorbid condition or medical history that, in the investigator's opinion, would interfere with study participation or interpretation of results.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Al Ahli hospital
Hebron, Palestine, P700
About this study
This interventional study investigates the efficacy of dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in pediatric patients with renal disease. The primary outcomes include changes in 24-hour proteinuria indexed to body surface area (mg/m²/day) and glomerular filtration rate (GFR) before and after dapagliflozin administration. By closely monitoring these parameters, the study aims to assess the renal protective potential of dapagliflozin in children and adolescents.
Read the detailed description
This is an interventional study designed to evaluate the effect of dapagliflozin, an SGLT2 inhibitor, on renal function in a pediatric population with underlying kidney disease. Eligible participants will include children and adolescents diagnosed with renal impairment.
All participants will receive dapagliflozin at an appropriate pediatric dose and will be followed over the study period. Baseline assessments will include measurement of serum creatinine, blood urea nitrogen (BUN), electrolytes, 24-hour urine protein normalized to body surface area (mg/m²/day), and estimated glomerular filtration rate (eGFR).
Follow-up evaluations will be conducted at regular intervals, with the same laboratory parameters measured to monitor both efficacy and safety. The primary endpoints are:
- Change in 24-hour proteinuria/m² before and after dapagliflozin therapy.
- Change in glomerular filtration rate (GFR) before and after treatment.
Secondary endpoints will include trends in serum creatinine, BUN, electrolyte balance, and tolerability of dapagliflozin in this age group. Safety monitoring will be performed throughout the study to detect potential adverse effects, such as hypoglycemia, dehydration, or urinary tract infections.
This study is expected to provide valuable evidence regarding the renal protective effects of dapagliflozin in pediatric patients, contributing to knowledge on its role as a novel therapeutic option in managing pediatric kidney disease.
- Conditions
- SGLT 2 Inhibitors, Pediatric Kidney Disease, Proteinuric Diseases, Dapagliflozin (Forxiga)
- Being tested
- Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy
- Keywords
- Pediatric kidney disease, Safety and efficacy, Kidney function biomarkers, Renal protection, Proteinuria, Dapagliflozin, Pediatric nephrology, SGLT2 inhibitors
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor TherapyDrug
Participants will receive dapagliflozin, an oral sodium-glucose cotransporter-2 (SGLT2) inhibitor, administered once daily at a dose of 5-10 mg. The intervention is intended to reduce proteinuria and provide nephroprotection in pediatric patients with kidney disease. Patients will be followed monthly, with monitoring of renal function markers (serum creatinine, blood urea nitrogen, and estimated glomerular filtration rate) and 24-hour urinary protein excretion normalized to body surface area, in addition to safety outcomes such as hypoglycemia, dehydration, and urinary tract infections.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin Treatment Arm | Experimental | This arm includes pediatric patients with kidney disease who receive dapagliflozin (5-10 mg daily) as an adjunct therapy. Participants are monitored monthly to assess efficacy and safety outcomes. Key renal function parameters measured include serum creatinine (Cr), blood urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), and 24-hour urinary protein excretion normalized to body surface area. Additional markers such as blood pressure, metabolic status, and potential adverse events (e.g., hypoglycemia, dehydration, urinary tract infections) are also evaluated. The purpose of this arm is to determine the effect of dapagliflozin on reducing proteinuria and improving renal outcomes in the pediatric population. Receives: Drug: Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of 24-hour proteinuria/m² before and after Dapagliflozin
Measured: Baseline to 12 months
Comparison of eGFR before and after Dapagliflozin
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start15 Aug 2025
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SGLT 2 InhibitorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Quds University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bassil A Leghrouz, MD, Study director, Al Ahli hospital-Palestine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204743
- Sponsor's protocol ID
- 382738738
- Status last verified
- Aug 2025
- First submitted
- 18 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Reeth O, Caliment A, de la Fuente Garcia I, Niel O. Safety Profile and Effectiveness of Dapagliflozin in Pediatric Patients with Chronic Kidney Disease. Am J Nephrol. 2024;55(4):463-467. doi: 10.1159/000539300. Epub 2024 May 14.
PubMed 38735286