Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients

Sponsor
Mansoura University
Study ID
NCT05748925
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • dapagliflozin — DRUG
    The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
  • placebo — DRUG
    Control group: will be maintained on their medication

Study Details

This study aims to assess sodium glucose linked transoprter inhibitors(SGT2i) role in regression of ongoing kidney and cardiac diseases among lupus nephritis patient either diabetic or non-diabetic under different immunosuppressive therapy. The main objective of this study is to: To compare use of sodium glucose linked transoprter inhibitors (SGLT2i) versus standard care in regression of chronic kidney disease in patient with lupus nephritis (LN). To study the safety and efficacy of this drug group with use of immunosuppression and possible interaction. Patients with an estimated glomerular filtration rate (eGFR) \>30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, Dapagliflozin 10 mg and 25 mg will be used once daily with or without food. Control group will be maintained on placebo.We will follow up all patients for 12 months and compare their results.

Key Dates

Start date
Oct 1, 2022
Status verified
Apr 2025
Primary completion
Jan 1, 2024
Completion
Jan 1, 2024

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: study group
    study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
  • Active Comparator: control group
    Control group: will receive placebo as add on drug once daily with or without food for one year.

Primary Outcome Measure

Effect of Dapagliflozin Compared to Placebo on Renal Function After One Year [ Time Frame: one year ]

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