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

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.

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Key information

Conditions

Lupus Nephritis (LN) ANCA Associated Vasculitis (AAV) Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Lupus Nephritis Male Urogenital Diseases Nephritis Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Urogenital Diseases Urologic Diseases Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gliflozin

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.

Primary outcomes

The variation of albuminuria

Time frame: From enrollment to the end of treatment at 6 months
The primary outcome is the variation of albuminuria after 6 months of treatment with SGLT-2i.

Time frame: From enrollment to the end of treatment at 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Ivana Capuano Researcher, Medicine

CONTACT

[email protected]

+39 0817464521

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 25, 2025
Registry last updated: Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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