Health TrialsbyHealthPanel

SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome

ConditionNephrotic Syndrome
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University

About this trial

This randomized controlled clinical trial aims to evaluate the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors (dapagliflozin and empagliflozin) in adult patients with primary nephrotic syndrome. The study will compare three groups: dapagliflozin plus standard therapy, empagliflozin plus standard therapy, and standard therapy alone.

The primary objective is to assess whether SGLT2 inhibitors reduce proteinuria, maintain remission, and prevent relapse. Secondary objectives include evaluating effects on kidney function (eGFR, serum creatinine) and monitoring safety outcomes.

Participants will continue their baseline standard care and will be followed for 6 months with regular clinical evaluations, laboratory tests, and adverse event monitoring.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Impaired liver functions (ALT or AST values exceeding 3 folds upper limit of normal (ULN) at the screening visit).

Glomerular hematuria (red blood cells more than ten cells per high power field (HPF) after routine urinalysis for more than three times in the last 2 weeks).

History of severe hypersensitivity or contraindications to dapagliflozin or empagliflozine.

Pregnancy or breastfeeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin

    Drug

    Dapagliflozin 10 mg PO once daily for 6 months

  • Empagliflozin

    Drug

    Empagliflozin 10 mg PO once daily for 6 month

  • Standard Therapy

    Other intervention

    immunosuppressive therapy and renoprotective agents for 6 months

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Dapagliflozin + Standard of CareExperimental treatment 2 interventions
Group B: Empagliflozin + Standard of CareExperimental treatment 2 interventions
Group C: Standard of Care OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

1. Change in Proteinuria (uPCR)

Change from baseline in urine protein/creatinine ratio

Time frame
Baseline to 6 months
2

Change in TNF-α Levels

Change in serum TNF-α measured by ELISA as an exploratory biomarker.

Time frame
Baseline to 6 months

Secondary outcomes

1

Change in Estimated Glomerular Filtration Rate (eGFR)

Mean change in eGFR calculated by CKD-EPI formula.

Time frame
Baseline to 6 months
2

Incidence of Adverse Events

Frequency and severity of adverse effects including infection, gastrointestinal upset, oral candidiasis, and other safety concerns.

Time frame
Throughout the 6-month study perio
3

Treatment Compliance

Proportion of participants with documented adherence to study medication and standard therapy.

Time frame
Up to 6 months
4

Remission Rate

Proportion of patients achieving remission

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov
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