SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis: Study Design and Protocol
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- The variation of albuminuria
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Lupus nephritis and ANCA associated vasculitis patients treated with glifozines
Intervention: Gliflozin (Drug)
Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Ivana Capuano
Researcher
Federico II University
