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Clinical Trials/NCT07035834
NCT07035834Not yet recruitingPhase 4

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

Federico II University0 sites40 target enrollmentStarted: September 1, 2025Last updated:
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Interventions

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
40
Primary Endpoint
The variation of albuminuria
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

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

Experimental

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

Sponsor
Federico II University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ivana Capuano

Researcher

Federico II University

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