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The Efficacy and Safety of SGLT2Is on Kidney Function, Proteinuria, and Estimated Glomular Filteration Rate (eGFR) in Lupus Nephritis Population

8 luglio 2026 aggiornato da: Ahmed Yehia Ismail

Does The Positive Reno-Protective Effect Of Sodium Glucose Co-Transporter 2 Inhibitors Extend To Lupus Nephritis Population?

Systemic lupus erythematosis (SLE) is a chronic, most probably auto-immune multisystem disease marked by relapsing-remitting course and the formation of a range of autoantibodies. SLE patients present with serious renal (lupus nephritis (LN)), cardiopulmonary, or nervous manifestation. LN occurs in 40%-70% of SLE cases during the first 10 years of disease and is marked by the presence of proteinuria (hallmark).

A novel class of medications had been extracted from phlorizin and indicated for the treatment of type 2 diabetes (T2D), referred to as Sodium glucose cotransporter 2 (SGLT-2) inhibitors. They act by decreasing glucose reabsorption in the proximal renal tubules (SGLT2). Previous studies proved that SGLT2 inhibitors resulted in decreased postprandial hyperglycemia, enhanced glycemic control, reduced body weight and blood pressure, and albuminuria in those with T2D. Large placebo-controlled trials such as Empagliflozin-Kidney (EMPA-Kidney) and Dapagliflozin in Patients with Chronic Kidney Disease (DAPA-CKD) trial demonstrated the efficacy of empagliflozin and dapagliflozin, respectively, in patients with chronic kidney disease (CKD) regardless the diabetic cause of CKD, compared to placebo. EMPA-Kidney with median 2.0 years of follow-up reported that empagliflozin (EMPA) significantly (P<0.001) lowered (13.1%) the risk of progression of kidney disease and death from cardiovascular causes than placebo (16.9%). Together with, DAPA-CKD trial reported that the risk of a composite of a sustained decline in the estimated GFR of at least 50% was significantly (P<0.001) lower in the DAPA group (9.2%) compared to placebo group (14.5%) over a median of 2.4 years of follow-up. However, such studies excluded lupus nephritis population from clinical trials.

Consequently, an experimental study is conducted to test the hypothesis that SGLT2 inhibitor EMPA is superior to placebo in improving proteinuria and estimated glomerular filtration rate (eGFR) in a group of patients with established LN already receiving the usual standard care and treatment.

The study is primarily designed to evaluate the reno-protective effect of EMPA on kidney function, in terms of urinary protein-creatinine ratio (uPCR)and eGFR.

Empagliflozin efficacy testing in lupus nephritis population (EMPA-LN) is a prospective, randomized, triple-blind, parallel-group, placebo controlled phase 4 trial recruiting 66 subjects. A 10% drop-out rate is anticipated based on the clinical opinion of the care provider. The study will be conducted in accordance with the declaration of Helsinki. An ethical approval will be provided from an ethics committee.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

66

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Egitto
      • Banī Suwayf, Egitto
        • Reclutamento
        • Beni-Suef university hospital
        • Contatto:
        • Sub-investigatore:
          • Seif

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Trial participants are adults (≥ 18 years) with established biopsy-proven LN of active III, IV, overlapping III/IV, or overlapping III/V classes, eGFR ≥ 30 ml.min 1.1.73m-2, and urinary protein creatinine ratio (uPCR) > 1000 mg/g.

Exclusion Criteria:

  • Subjects with serious hypersensitivity (angioedema and/or anaphylaxis) to EMPA, eGFR < 30 ml.min-1.1.73m-2, uPCR < 1000 mg/g, type 1 or 2 diabetes, aterial fibrillation, hepatic impairment [defined as alanine transaminase or aspartate transaminase >3 times the upper limit of normal (ULN) or total bilirubin >2 times the ULN at the time of enrolment], any condition outside the renal and cardiovascular study area with a life expectancy of < 6 months based on care provider's clinical judgment, and those who enrolled in an experimental study in the previous 6 months are excluded from recruitment in EMPA-LN clinical trial.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo una volta al giorno
Droga: Placebo and standard of care
The placebo includes a matching tablet similar to empagliflozin tablet in shape, color, and size. Each participant randomly assigned to the Placebo group will administer one tablet each day along with the usual standard medical therapy
Sperimentale: Empagliflozin 25 mg once daily
Droga: Empagliflozin (25 Mg Tab) along with standard medical therapy
The intervention includes empagliflozin 25 mg once daily, empagliflozin is a sodium glucose cotransporter-2 inhibitor (SGLT2I) medication that provides a glycemic control, furthermore, it is reported its antiproteinuric effect and improving the kidney function. Each participant randomly assigned to the interventional group will administer one tablet each day provided with the usual standard care therapy
Altri nomi:
  • EMPA
  • SGLT2Is

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Urinary protein-creatinine ratio (UPCR)
Lasso di tempo: From recruitment (week 0) to the end of treatment (week 12)
The difference in change in UPCR from baseline to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between both the placebo and EMPA groups.
From recruitment (week 0) to the end of treatment (week 12)
Estimated glomerular filtration rate (eGFR)
Lasso di tempo: From recruitment (week 0) to the end of treatment (week 12)
The difference in change in eGFR from baseline to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between both the placebo and EMPA groups.
From recruitment (week 0) to the end of treatment (week 12)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The tolerance and safety
Lasso di tempo: From enrollment (week 0) to 4 weeks following the end of the treatment (week 12)
The relative risk of adverse events reported between both treatment groups at 4 weeks following the end of the treatment (3 months).
From enrollment (week 0) to 4 weeks following the end of the treatment (week 12)
Fasting plasma glucose (FBG)
Lasso di tempo: From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in FBG to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between study groups.
From enrollment (week 0) to the end of treatment (week 12)
Systolic (SBP) and diastolic (DBP) blood pressure
Lasso di tempo: From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in systolic (SBP) and diastolic blood pressure (DBP) to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between study groups.
From enrollment (week 0) to the end of treatment (week 12)
Hemoglobin (Hb) level
Lasso di tempo: From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in Hb level to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between study groups.
From enrollment (week 0) to the end of treatment (week 12)
Hematocrit level
Lasso di tempo: From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in hematocrit level to the first follow-up (1.5 months) and to the end of the treatment period (3 months) between study groups.
From enrollment (week 0) to the end of treatment (week 12)
Glycated hemoglobin (HbA1c)
Lasso di tempo: From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in HbA1c to the end of the treatment period (3 months) between study groups
From enrollment (week 0) to the end of treatment (week 12)
Adverse events and safety
Lasso di tempo: From enrollment (week 0) to the end of treatment (week 12)
The proportion of adverse events reported in EMPA and placebo groups throughout the research study (3 months).
From enrollment (week 0) to the end of treatment (week 12)
Partial response
Lasso di tempo: From enrollment (week 0) to the end of treatment (week 12)
Proportion of subjects that reach partial renal response in terms of UPCR (defined as ≥ 50% decline in UPCR from baseline value to ˂ 3000 mg/g of creatinine from a 24-h urine collection)
From enrollment (week 0) to the end of treatment (week 12)
Body weight
Lasso di tempo: From enrollment (week 0) to the end of treatment (week 12)
The difference in change from baseline in body weight to 1st follow-up (1.5 months) and to the end of the treatment period (3 months) between study groups.
From enrollment (week 0) to the end of treatment (week 12)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ahmed Yehia Ismail

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 gennaio 2024

Completamento primario (Stimato)

30 dicembre 2026

Completamento dello studio (Stimato)

30 dicembre 2026

Date di iscrizione allo studio

Primo inviato

8 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 novembre 2025

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GLIFALN0066

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Prove cliniche su Empagliflozin (25 Mg Tab) along with standard medical therapy

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