SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis

Federico II University

Status and phase: Not yet enrolling; Phase 4

Conditions: ANCA Associated Vasculitis (AAV); Lupus Nephritis (LN)

Treatments: Drug: Gliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT07035834

IC001

Details and patient eligibility

About

The goal of this clinical trial is to investigate the effect of the glifozines on albuminuria in chronic kidney disease patients affected by lupus nephritis and ANCA associated renal vasculitis. It will also learn about the safety of glifozines. The main questions it aims to answer are:

• Does glifozines lower the albuminuria of participants with chronic kidney disease secondary to lupus nephritis and ANCA associated renal vasculitis?
• What medical problems do participants have when taking glifozines?

Participants will:

• Take glifozines every day for 6 months.
• Baseline, 1 month and 6-month visits will be scheduled to collect demographic, clinical, biochemical, and urinary data.
• A psychosocial assessment will be performed.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged more than18 years with chronic kidney disease from stage 1 to3, secondary to confirmed LN, without active LN, and AAV

Exclusion criteria

• 1. allergy or intolerance to SGLT2i exposure within 1month before screening; 2) recurrent urinary tract infections; 3) hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase levels >2 times the upper normal limits); 4) an eGFR ˂30 ml/min/1.73 m2; 5) DM type I and II.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Lupus nephritis and ANCA associated vasculitis patients treated with glifozines

Experimental group

Treatment:

Drug: Gliflozin