SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients

Sponsor
Mansoura University
Study ID
NCT05704088
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin tablet — DRUG
    randomized control trial, study group will receive dapagliflozin tablets
  • placebo — DRUG
    randomized control trial, control group will receive placebo tablets

Study Details

The goal of this Randomized, controlled trial in 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center. 1\. The main questions it aims to answer are: * Assess the role of sodium glucose co transporter 2 inhibitors (SGLT2i) in regression of ongoing kidney and cardiac diseases among diabetic or non-diabetic patients with lupus nephritis (LN) under different immunosuppressive therapies. * Investigate the impact of SGLT2i on bone and mineral metabolism in these patients. Participants 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. * Control group: will be maintained on their medication.

Key Dates

Start date
Oct 8, 2022
Status verified
Oct 2024
Primary completion
Jan 8, 2024
Completion
Jan 8, 2024

Study Design

Enrollment
100 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 year.
  • Placebo 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 on renal function [ Time Frame: 1 year ]

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