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

NCT ID: NCT07035834

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lupus nephritis and ANCA associated vasculitis patients treated with glifozines

Group Type: EXPERIMENTAL

Gliflozin

Intervention Type: DRUG

Our study will enroll non diabetic patients affected by chronic kidney disease secondary to lupus nephritis and ANCA associated vasculitis. Other studies have so far investigated only diabetic patients affected by the above mentioned diseases.

Interventions

Gliflozin

Our study will enroll non diabetic patients affected by chronic kidney disease secondary to lupus nephritis and ANCA associated vasculitis. Other studies have so far investigated only diabetic patients affected by the above mentioned diseases.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Ivana Capuano

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ivana Capuano Researcher, Medicine

Role: CONTACT

ivana.capuano@unina.it

+39 0817464521

Other Identifiers

IC001

Identifier Type: -

Identifier Source: org_study_id