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

NCT07035834 | Not Yet Recruiting Phase 4

• 1 other identifier: IC001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Lupus Nephritis; ANCA associated vasculitis; SGLT-2 inhibitors; nephroprotection

Outcome Measures

Primary Outcomes (2)

• The variation of albuminuria

  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.

  From enrollment to the end of treatment at 6 months

Study Arms (1)

Lupus nephritis and ANCA associated vasculitis patients treated with glifozines

EXPERIMENTAL

Drug: Gliflozin

Interventions

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.

Lupus nephritis and ANCA associated vasculitis patients treated with glifozines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Federico II University: lead

MeSH Terms

Conditions

Lupus Nephritis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Central Study Contacts

Ivana Capuano Researcher, Medicine

CONTACT

+39 0817464521; ivana.capuano@unina.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share