Menu
Not yet recruiting NCT07035834

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

Phase IV Interventional Lupus Nephritis (LN) ANCA Associated Vasculitis (AAV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gliflozin.
Who it may be relevant to
Registry conditions: Lupus Nephritis (LN), ANCA Associated Vasculitis (AAV). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Gliflozin
    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 outcome measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07035834 · IC001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗