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

• Status: Active, not recruiting
• Trial end date: 2023-12-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• Age of patient is more than 18.

• Patients who are willing to sign informed consent.

• Patients with SLE diagnosed according to EULAR/ACR classification criteria.

• Patients with LN according to renal biopsy.

• Patients with eGFR > 30 ml/min/1.73m2.

Exclusion Criteria:

• With eGFR <30 ml/min per 1.73 m2.

• Who is currently pregnancy or lactation.

• With medical history of chronic disease (chronic liver disease, cancer, severe respiratory distress, gastrointestinal tract lesions).

• Refuse to participate in the study or lost follow up.

• With evidence of urinary obstruction of difficulty in voiding at screening.

• Who are receiving high dose diuretics or combined angiotensin-converting enzyme inhibitor (ACEI) and Angiotensin II receptor blockers (ARBS).

• Who have frequent hypotensive episode or systolic blood pressure <100 mmHg. Active malignancy.

• Active infection including HIV.

• Any medications that may affect or interact with bone metabolism such as calcitonin, , denosumab, estrogen and fluoride during the last 6 months.

• Current or previous organ transplantation, or expected to get a kidney transplant within 12 months