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The Efficacy of Empagliflozin on Kidney Functions in Lupus Nephritis Population

14 juillet 2026 mis à jour par: 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 trial participants compatabile with the elgibility criteria will be randomly assigned to two groups. One group will take Empagliflozin 25 mg tablet each day along with the standard care therapy. The other group will take a matching placebo besides the usual standard care therapy during the clinical trial period.

Study outcomes will be measured three times, one before starting the medical study, the second and third will be 6 and 12 weeks after starting the clinical study, respectively. After that, the statistical siginficance of values between both groups will be reported to test the credibilty of the hypothesis.

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-blinded, 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

66

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Egypte
      • Banī Suwayf, Egypte
        • Recrutement
        • Beni-suef university Hospital
        • Contact:
        • Sous-enquêteur:
          • Seif

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Adults (≥ 18 years) with established biopsy-proven LN of active III, IV, overlapping III/IV, or overlapping III/V classes.
  • eGFR ≥ 30 ml.min1.1.73m-2,
  • 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.
  • Those who enrolled in an experimental study in the previous 6 months.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo une fois par jour
Médicament: 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 within the clinical study period
Autres noms:
  • Placebo correspondant
  • inactive gredient
Expérimental: Empagliflozin 25 mg once daily
Médicament: Empagliflozin (25 Mg Tab) along with standard medical therapy
The intervention includes empagliflozin 25 mg tablet 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 within the clinical study period.
Autres noms:
  • EMPA
  • SGLT2Is

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Urinary protein-creatinine ratio (UPCR)
Délai: 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)
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The tolerance and safety
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ahmed Yehia Ismail

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 janvier 2024

Achèvement primaire (Estimé)

30 décembre 2026

Achèvement de l'étude (Estimé)

30 décembre 2026

Dates d'inscription aux études

Première soumission

8 juillet 2026

Première soumission répondant aux critères de contrôle qualité

8 juillet 2026

Première publication (Réel)

14 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juillet 2026

Dernière vérification

1 novembre 2025

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GLIFALN0066

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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