Clinical Value of Adding Dapagliflozin in Patients With Nephrotic Syndrome

NCT06026787 | Completed Phase 4

• 1 other identifier: MS 419/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Conducted as a randomized controlled clinical trial, this study aims to assess the potential benefits of incorporating dapagliflozin, an SGLT-2 inhibitor, into the treatment regimen of patients diagnosed with primary nephrotic syndrome. The primary focus is on examining the impact of dapagliflozin on two key parameters: proteinuria and estimated glomerular filtration rate (eGFR). The trial involves adult participants who have been definitively diagnosed with primary nephrotic syndrome through renal biopsy. In conjunction with their standard care, these participants will receive a daily dose of dapagliflozin at 10 mg. Over a span of six months, they will undergo comprehensive monthly assessments. These assessments will involve the collection and analysis of urine samples to quantify proteinuria and perform urinalysis. Additionally, blood samples will be taken to determine the estimated eGFR, lipid profile, glycated hemoglobin. Participants will also be encouraged to report any potential side effects resulting from their medication intake.

Conditions

Nephrotic Syndrome; Sodium-Glucose Transporter 2 Inhibitors

Outcome Measures

Primary Outcomes (2)

• Proteinuria

  Effect of dapagliflozin on proteinuria

  6 months

• Estimated GFR

  6 months

Other Outcomes (2)

• Lipid profile

  6 months

• Body Weight

  6 months

Study Arms (2)

Dapagliflozin Arm

EXPERIMENTAL

During the study duration of 6 months, this cohort will be administered a daily dose of 10 mg dapagliflozin in conjunction with the standard of care for primary nephrotic syndrome based on the KDIGO 2021 guidelines. The conventional treatment regimen may encompass immunosuppressive medications, agents that block the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as deemed necessary.

Drug: Dapagliflozin 10mg Tab

Control Arm

NO INTERVENTION

This cohort will exclusively be subjected to the standard of care tailored for primary nephrotic syndrome. This could encompass administration of immunosuppressive drugs, agents targeting the renin-angiotensin-aldosterone system (RAAS), statins, and diuretics as warranted by individual needs.

Interventions

Dapagliflozin 10mg Tab DRUG

Dapagliflozin 10 mg will be added to the standard of care regimen of primary nephrotic syndrome patients

Dapagliflozin Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eGFR \> 25 mL/min/1.73m2
• Evidence of primary nephrotic syndrome by renal biopsy
• Non-diabetic kidney disease

You may not qualify if:

• Nephrotic syndrome secondary to lupus nephritis, AAV, amyloidosis, or secondary membranous nephropathy
• Hepatic impairment \[AST or ALT \>3 times ULN or total bilirubin \>2 times the ULN\] at the time of enrolment
• Pregnant or breast-feeding females

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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 31, 2023
• First Posted: September 7, 2023
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-08

Locations

EG (1)