NCT07035834Not yet recruitingPhase 4
SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis
SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis: Study Design and Protocol
Source: ClinicalTrials.gov · Last updated 25 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 16 Jun 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Federico II University
- NCT number
- NCT07035834
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 40
- From 1 Sept 2025 to the primary completion date, 30 Sept 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- patients aged more than18 years with chronic kidney disease from stage 1 to3, secondary to confirmed LN, without active LN, and AAV
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.