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

July 8, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Banī Suwayf, Egypt
        • Recruiting
        • Beni-Suef university hospital
        • Contact:
        • Sub-Investigator:
          • Seif

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo once daily
Drug: 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
Experimental: Empagliflozin 25 mg once daily
Drug: 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
Other Names:
  • EMPA
  • SGLT2Is

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary protein-creatinine ratio (UPCR)
Time Frame: 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)
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The tolerance and safety
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed Yehia Ismail

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLIFALN0066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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