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Lupus Nephritis (LN)Phase 4NCT07700940

The Efficacy of Empagliflozin on Kidney Functions in Lupus Nephritis Population

A Phase 4 study testing Empagliflozin (25 Mg Tab) along with standard medical therapy in people with Lupus Nephritis (LN), run by Ahmed Yehia Ismail at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lupus Nephritis (LN)
What is being tested?
Empagliflozin (25 Mg Tab) along with standard medical therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteEgypt
Study dates
22 Jan 2024to 30 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Associate professor. Ahmed Yehia contact

+201090905827 ext. +20

ahmed_yehia@med.bsu.edu.eg

Egypt1 site, 1 recruiting

  • Beni-Suef university hospital

    Banī Suwayf

    Associate professor. Ahmed Yehia, +201090905827 ext. +20, ahmed_yehia@med.bsu.edu.eg

    Seif

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read more

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.

Being tested
Empagliflozin (25 Mg Tab) along with standard medical therapy, Placebo and standard of care
Medical subject headings
Lupus Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin (25 Mg Tab) along with standard medical therapyDrug

    Also called EMPA, SGLT2Is

    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.

  • Placebo and standard of careDrug

    Also called Matching placebo, inactive gredient

    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

Study groups in NCT07700940
Study groupRoleWhat they receive
Empagliflozin 25 mg once dailyExperimentalNot described
Receives: Drug: Empagliflozin (25 Mg Tab) along with standard medical therapy
Placebo once dailyPlacebo comparatorNot described
Receives: Drug: Placebo and standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urinary protein-creatinine ratio (UPCR)

    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.

    Measured: From recruitment (week 0) to the end of treatment (week 12)

  2. Estimated glomerular filtration rate (eGFR)

    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.

    Measured: From recruitment (week 0) to the end of treatment (week 12)

Secondary outcomes (9)

  1. The tolerance and safety

    The relative risk of adverse events reported between both treatment groups at 4 weeks following the end of the treatment (3 months).

    Measured: From enrollment (week 0) to 4 weeks following the end of the treatment (week 12)

  2. Fasting plasma glucose (FBG)

    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.

    Measured: From enrollment (week 0) to the end of treatment (week 12)

  3. Systolic (SBP) and diastolic (DBP) blood pressure

    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.

    Measured: From enrollment (week 0) to the end of treatment (week 12)

  4. Hemoglobin (Hb) level

    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.

    Measured: From enrollment (week 0) to the end of treatment (week 12)

  5. Hematocrit level

    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.

    Measured: From enrollment (week 0) to the end of treatment (week 12)

  6. Glycated hemoglobin (HbA1c)

    The difference in change from baseline in HbA1c to the end of the treatment period (3 months) between study groups

    Measured: From enrollment (week 0) to the end of treatment (week 12)

  7. Adverse events and safety

    The proportion of adverse events reported in EMPA and placebo groups throughout the research study (3 months).

    Measured: From enrollment (week 0) to the end of treatment (week 12)

  8. Partial response

    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)

    Measured: From enrollment (week 0) to the end of treatment (week 12)

  9. Body weight

    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.

    Measured: From enrollment (week 0) to the end of treatment (week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start22 Jan 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07700940
Sponsor's protocol ID
GLIFALN0066
Status last verified
Nov 2025
First submitted
8 Jul 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Piperidou A, Sarafidis P, Boutou A, Thomopoulos C, Loutradis C, Alexandrou ME, Tsapas A, Karagiannis A. The effect of SGLT-2 inhibitors on albuminuria and proteinuria in diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials. J Hypertens. 2019 Jul;37(7):1334-1343. doi: 10.1097/HJH.0000000000002050.

    PubMed 31145707

  • McMurray JJV, Wheeler DC, Stefansson BV, Jongs N, Postmus D, Correa-Rotter R, Chertow GM, Greene T, Held C, Hou FF, Mann JFE, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effect of Dapagliflozin on Clinical Outcomes in Patients With Chronic Kidney Disease, With and Without Cardiovascular Disease. Circulation. 2021 Feb 2;143(5):438-448. doi: 10.1161/CIRCULATIONAHA.120.051675. Epub 2020 Nov 13.

    PubMed 33186054

  • Serenelli M, Bohm M, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, DeMets DL, Bengtsson O, Sjostrand M, Langkilde AM, Anand IS, Chiang CE, Chopra VK, de Boer RA, Diez M, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Verma S, Docherty KF, Jhund PS, McMurray JJV. Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF). Eur Heart J. 2020 Sep 21;41(36):3402-3418. doi: 10.1093/eurheartj/ehaa496.

    PubMed 32820334

  • Wheeler DC, Stefansson BV, Batiushin M, Bilchenko O, Cherney DZI, Chertow GM, Douthat W, Dwyer JP, Escudero E, Pecoits-Filho R, Furuland H, Gorriz JL, Greene T, Haller H, Hou FF, Kang SW, Isidto R, Khullar D, Mark PB, McMurray JJV, Kashihara N, Nowicki M, Persson F, Correa-Rotter R, Rossing P, Toto RD, Umanath K, Van Bui P, Wittmann I, Lindberg M, Sjostrom CD, Langkilde AM, Heerspink HJL. The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics. Nephrol Dial Transplant. 2020 Oct 1;35(10):1700-1711. doi: 10.1093/ndt/gfaa234.

    PubMed 32862232

  • McEwan P, Darlington O, McMurray JJV, Jhund PS, Docherty KF, Bohm M, Petrie MC, Bergenheim K, Qin L. Cost-effectiveness of dapagliflozin as a treatment for heart failure with reduced ejection fraction: a multinational health-economic analysis of DAPA-HF. Eur J Heart Fail. 2020 Nov;22(11):2147-2156. doi: 10.1002/ejhf.1978. Epub 2020 Sep 15.

    PubMed 32749733

  • Leoncini G, Russo E, Bussalino E, Barnini C, Viazzi F, Pontremoli R. SGLT2is and Renal Protection: From Biological Mechanisms to Real-World Clinical Benefits. Int J Mol Sci. 2021 Apr 23;22(9):4441. doi: 10.3390/ijms22094441.

    PubMed 33922865

  • Emmett CJ, Stewart GR, Johnson RM, Aswani SP, Chan RL, Jakeman LB. Distribution of radioiodinated recombinant human nerve growth factor in primate brain following intracerebroventricular infusion. Exp Neurol. 1996 Aug;140(2):151-60. doi: 10.1006/exnr.1996.0125.

    PubMed 8690058

  • Herrington WG, Savarese G, Haynes R, Marx N, Mellbin L, Lund LH, Dendale P, Seferovic P, Rosano G, Staplin N, Baigent C, Cosentino F. Cardiac, renal, and metabolic effects of sodium-glucose co-transporter 2 inhibitors: a position paper from the European Society of Cardiology ad-hoc task force on sodium-glucose co-transporter 2 inhibitors. Eur J Heart Fail. 2021 Aug;23(8):1260-1275. doi: 10.1002/ejhf.2286. Epub 2021 Jul 20.

    PubMed 34184823

  • The EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Wanner C, Green JB, Hauske SJ, Emberson JR, Preiss D, Judge P, Mayne KJ, Ng SYA, Sammons E, Zhu D, Hill M, Stevens W, Wallendszus K, Brenner S, Cheung AK, Liu ZH, Li J, Hooi LS, Liu W, Kadowaki T, Nangaku M, Levin A, Cherney D, Maggioni AP, Pontremoli R, Deo R, Goto S, Rossello X, Tuttle KR, Steubl D, Petrini M, Massey D, Eilbracht J, Brueckmann M, Landray MJ, Baigent C, Haynes R. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023 Jan 12;388(2):117-127. doi: 10.1056/NEJMoa2204233. Epub 2022 Nov 4.

    PubMed 36331190

  • Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.

    PubMed 32970396

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin (25 Mg Tab) along with standard medical therapy in people with Lupus Nephritis (LN), run by Ahmed Yehia Ismail at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Associate professor. Ahmed Yehia (+201090905827 ext. +20, ahmed_yehia@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary protein-creatinine ratio (UPCR) (time frame: From recruitment (week 0) to the end of treatment (week 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07700940, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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