SLEPhase 4NCT05748925
Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients
A Phase 4 study testing dapagliflozin in people with SLE and Lupus Nephritis, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to assess sodium glucose linked transoprter inhibitors(SGT2i) role in regression of ongoing kidney and cardiac diseases among lupus nephritis patient either diabetic or non-diabetic under different immunosuppressive therapy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- SLE, Lupus Nephritis, SGLT2 Inhibitors
- What is being tested?
- dapagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Jan 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged more than 16 year.
- Willing to sign informed consent.
- Diagnosis of SLE according to EULAR/ACR classification criteria.
- Renal biopsy showed lupus nephritis.
- Patient with eGFR > 30 ml/min/1.73m2 by cockcroft-gault equation.
Who cannot join
- Patients with eGFR <30 ml/min per 1.73 m2.
- Current pregnancy or lactation.
- Medical history of chronic disease (CLD, cancer, severe respiratory distress, gastrointestinal tract lesions).
- Patients refusing to participate in the study or lost follow up.
- Evidence of urinary obstruction of difficulty in voiding at screening.
- Patients who are receiving high dose diuretics or combined ACEI, Angiotensin II receptor blockers (ARBS).
- Patients who have frequent hypotensive episode or SBP <100 mmHg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Cardio Renal Effects of SGLT2 Inhibitors Among Diabetic and Non-diabetic Lupus Nephritis Patients
This study aims to assess sodium glucose linked transoprter inhibitors(SGT2i) role in regression of ongoing kidney and cardiac diseases among lupus nephritis patient either diabetic or non-diabetic under different immunosuppressive therapy.
The main objective of this study is to:
Read more
To compare use of sodium glucose linked transoprter inhibitors (SGLT2i) versus standard care in regression of chronic kidney disease in patient with lupus nephritis (LN).
To study the safety and efficacy of this drug group with use of immunosuppression and possible interaction.
Patients with an estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, Dapagliflozin 10 mg and 25 mg will be used once daily with or without food.
Control group will be maintained on placebo.We will follow up all patients for 12 months and compare their results.
Read the detailed description
Study sitting:
Nephrology and renal transplant unit at urology and nephrology center in Mansoura University.
It will include 100 patients with lupus nephritis, Diagnosis of glomerulonephritis was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
Patients with an estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, dapagliflozin 10 mg and 25 mg will be used once daily with or without food.
Control group will be maintained on placebo. The primary endpoint will be sustained decline in eGFR ≥50%, ESKD, or kidney or cardiovascular death We will follow up all patients for 12 months and compare their results.
- Inclusion criteria: Patients aged more than 16 year. Willing to sign informed consent. Diagnosis of Systemic Lupus Erythematosus (SLE) according to american college of rheumatology (ACR) classification criteria.
Renal biopsy showed lupus nephritis. Patient with eGFR > 30 ml/min/1.73m2 by cockcroft-gault equation. 3. Exclusion criteria: Patients with eGFR <30 ml/min per 1.73 m2. Current pregnancy or lactation. Medical history of chronic disease (CLD, cancer, severe respiratory distress, gastrointestinal tract lesions).
Patients refusing to participate in the study or lost follow up. Evidence of urinary obstruction of difficulty in voiding at screening. Patients who are receiving high dose diuretics or combined Angiotensin converting enzymes inhibitors(ACEI) and Angiotensin II receptor blockers (ARBS).
Patients who have frequent hypotensive episode or systolic blood pressure (SBP) <100 mmHg.
Operational design:
Study Protocol:
Patients included in the study will treated with dapaglifilozin initiated at a total daily dosage of 10 mg/kg per day.
Study design:
Type of the study: randomized controlled study.
The following data will be gathered and evaluated for all patients:
I-before intervention:
Serum creatinine, Creatinine clearance. 24 hour urine protein, urine protein/creatinine ratio. Urine analysis. HBA1c. Hemoglobin (HGB). Uric acid and lipid profile. Lupus serology.
II-after intervention: All patients will be evaluated monthly regarding:
Serum creatinine, creatinine clearance. 24 hour proteinuria, protein/creatinine ratio. Fasting, random and postprandial glucose levels. calcineurin inhibitors (CNI) trough level if used. Urine analysis. HGB level. Uric acid, lipid profile. Lupus serology.
Cardiovascular assessment:
Echocardiogram. Atherosclerosis and vascular calcification incidence (NCCT model). Regular measurement of blood pressure each visit
ll patients will be evaluated at 12 month regarding:
- erythropoetin level
- Hepcidin level.
- Conditions
- SLE, Lupus Nephritis, SGLT2 Inhibitors
- Being tested
- dapagliflozin, placebo
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapagliflozinDrug
The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
placeboDrug
Control group: will be maintained on their medication
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye Receives: Drug: dapagliflozin |
| control group | Active comparator | Control group: will receive placebo as add on drug once daily with or without food for one year. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Dapagliflozin Compared to Placebo on Renal Function After One Year
Effect of dapagliflozin compared to placebo on eGFR,24- hour urinary protein
Measured: one year
Cardiovascular Assessment in Two Groups
Coronary artery calcification will be measured using non-contrast computed tomography (NCCT). The Agatston score, a standardized method for quantifying coronary calcification, will be used to assess and compare baseline and 1-year follow-up measurements between the dapagliflozin and placebo groups.
Measured: 1 year
Effect of Dapagliflozin Compared to Placebo on Erythropoietin Level
Erythropoietin level will be measured in two groups before and after intervention
Measured: 1 year
Effect of Dapagliflozin Compared to Placebo on Hepcidin Level
hepcidin level will be measured in two groups before and after intervention
Measured: 1 year
Effect of Dapagliflozin Compared to Placebo on Renal Function
Effect of dapagliflozin compared to placebo on 24- hour urinary protein after 1 year
Measured: 1 year
Effect of Dapagliflozin Compared to Placebo on Renal Function
Effect of Dapagliflozin Compared to Placebo on Renal Function on uric acid after 1 year
Measured: 1 year
Secondary outcomes (2)
Effect of Dapagliflozin Compared to Placebo on ECCHO Parameters
ECCHO will be done before and after intervention
Measured: 1 year
Effect of Dapagliflozin Compared to Placebo on Body Weight
body weight will be assessed throughout the study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Oct 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SLEStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial, It will include 100 patients with lupus nephritis, Diagnosis of glomerulonephritis was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center. Patients with an estimated glomerular filtration rate (eGFR) \>30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, Dapagliflozin 10 mg and 25 mg will be used once daily with or without food. Control group will be maintained on placebo.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourelsabah Mohamed, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748925
- Sponsor's protocol ID
- MD.21.10.550
- Status last verified
- Apr 2025
- First submitted
- 18 Feb 2023
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data (IPD) that underlie results in a publication
Publications
Mohamed N, Zayed KN, Elhadedy MA, Badawi MH, Mortada WI, Nabieh KA, Sobh MA, Refaie AF. Dapagliflozin in lupus nephritis: renal and hematologic outcomes from a randomized controlled trial. Clin Kidney J. 2026 Jul 10;19(8):sfag231. doi: 10.1093/ckj/sfag231. eCollection 2026 Aug.
PubMed 42549085
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Cardio Renal Effects of SGLT2 Inhibitors Among Diabetic and Non-diabetic Lupus Nephritis Patients
- ClinicalTrials.gov ID
- NCT05748925
- Acronym / sponsor ID
- MD.21.10.550
- Conditions
- SLE, Lupus Nephritis, SGLT2 Inhibitors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess sodium glucose linked transoprter inhibitors(SGT2i) role in regression of ongoing kidney and cardiac diseases among lupus nephritis patient either diabetic or non-diabetic under different immunosuppressive therapy.
The main objective of this study is to:
To compare use of sodium glucose linked transoprter inhibitors (SGLT2i) versus standard care in regression of chronic kidney disease in patient with lupus nephritis (LN).
To study the safety and efficacy of this drug group with use of immunosuppression and possible interaction.
Patients with an estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, Dapagliflozin 10 mg and 25 mg will be used once daily with or without food.
Control group will be maintained on placebo.We will follow up all patients for 12 months and compare their results.
Detailed description
Study sitting:
Nephrology and renal transplant unit at urology and nephrology center in Mansoura University.
It will include 100 patients with lupus nephritis, Diagnosis of glomerulonephritis was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
Patients with an estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, dapagliflozin 10 mg and 25 mg will be used once daily with or without food.
Control group will be maintained on placebo. The primary endpoint will be sustained decline in eGFR ≥50%, ESKD, or kidney or cardiovascular death We will follow up all patients for 12 months and compare their results.
- Inclusion criteria: Patients aged more than 16 year. Willing to sign informed consent. Diagnosis of Systemic Lupus Erythematosus (SLE) according to american college of rheumatology (ACR) classification criteria.
Renal biopsy showed lupus nephritis. Patient with eGFR > 30 ml/min/1.73m2 by cockcroft-gault equation. 3. Exclusion criteria: Patients with eGFR <30 ml/min per 1.73 m2. Current pregnancy or lactation. Medical history of chronic disease (CLD, cancer, severe respiratory distress, gastrointestinal tract lesions).
Patients refusing to participate in the study or lost follow up. Evidence of urinary obstruction of difficulty in voiding at screening. Patients who are receiving high dose diuretics or combined Angiotensin converting enzymes inhibitors(ACEI) and Angiotensin II receptor blockers (ARBS).
Patients who have frequent hypotensive episode or systolic blood pressure (SBP) <100 mmHg.
Operational design:
Study Protocol:
Patients included in the study will treated with dapaglifilozin initiated at a total daily dosage of 10 mg/kg per day.
Study design:
Type of the study: randomized controlled study.
The following data will be gathered and evaluated for all patients:
I-before intervention:
Serum creatinine, Creatinine clearance. 24 hour urine protein, urine protein/creatinine ratio. Urine analysis. HBA1c. Hemoglobin (HGB). Uric acid and lipid profile. Lupus serology.
II-after intervention: All patients will be evaluated monthly regarding:
Serum creatinine, creatinine clearance. 24 hour proteinuria, protein/creatinine ratio. Fasting, random and postprandial glucose levels. calcineurin inhibitors (CNI) trough level if used. Urine analysis. HGB level. Uric acid, lipid profile. Lupus serology.
Cardiovascular assessment:
Echocardiogram. Atherosclerosis and vascular calcification incidence (NCCT model). Regular measurement of blood pressure each visit
ll patients will be evaluated at 12 month regarding:
- erythropoetin level
- Hepcidin level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- randomized controlled trial, It will include 100 patients with lupus nephritis, Diagnosis of glomerulonephritis was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center. Patients with an estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, Dapagliflozin 10 mg and 25 mg will be used once daily with or without food. Control group will be maintained on placebo.
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Drug: dapagliflozinstudy group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye |
| control group | Active comparator | Drug: placeboControl group: will receive placebo as add on drug once daily with or without food for one year. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged more than 16 year.
- Willing to sign informed consent.
- Diagnosis of SLE according to EULAR/ACR classification criteria.
- Renal biopsy showed lupus nephritis.
- Patient with eGFR > 30 ml/min/1.73m2 by cockcroft-gault equation.
Key exclusion criteria (7 listed)
- Patients with eGFR <30 ml/min per 1.73 m2.
- Current pregnancy or lactation.
- Medical history of chronic disease (CLD, cancer, severe respiratory distress, gastrointestinal tract lesions).
- Patients refusing to participate in the study or lost follow up.
- Evidence of urinary obstruction of difficulty in voiding at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dapagliflozinThe patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food. | Drug | study group |
| placeboControl group: will be maintained on their medication | Drug | control group |
Primary outcome
Effect of Dapagliflozin Compared to Placebo on Renal Function After One Year
Time frame: one year
Effect of dapagliflozin compared to placebo on eGFR,24- hour urinary protein
Cardiovascular Assessment in Two Groups
Time frame: 1 year
Coronary artery calcification will be measured using non-contrast computed tomography (NCCT). The Agatston score, a standardized method for quantifying coronary calcification, will be used to assess and compare baseline and 1-year follow-up measurements between the dapagliflozin and placebo groups.
Effect of Dapagliflozin Compared to Placebo on Erythropoietin Level
Time frame: 1 year
Erythropoietin level will be measured in two groups before and after intervention
Effect of Dapagliflozin Compared to Placebo on Hepcidin Level
Time frame: 1 year
hepcidin level will be measured in two groups before and after intervention
Effect of Dapagliflozin Compared to Placebo on Renal Function
Time frame: 1 year
Effect of dapagliflozin compared to placebo on 24- hour urinary protein after 1 year
Effect of Dapagliflozin Compared to Placebo on Renal Function
Time frame: 1 year
Effect of Dapagliflozin Compared to Placebo on Renal Function on uric acid after 1 year
2 secondary outcomes
Effect of Dapagliflozin Compared to Placebo on ECCHO Parameters
Time frame: 1 year
Effect of Dapagliflozin Compared to Placebo on Body Weight
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42549085Mohamed N, Zayed KN, Elhadedy MA, Badawi MH, Mortada WI, Nabieh KA, Sobh MA, Refaie AF. Dapagliflozin in lupus nephritis: renal and hematologic outcomes from a randomized controlled trial. Clin Kidney J. 2026 Jul 10;19(8):sfag231. doi: 10.1093/ckj/sfag231. eCollection 2026 Aug.
- Individual participant dataSharing planned: Yes. all individual participant data (IPD) that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dapagliflozin in people with SLE and Lupus Nephritis, run by Mansoura University 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 16 Apr 2025. 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. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Dapagliflozin Compared to Placebo on Renal Function After One Year (time frame: one year). The study lists 6 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 NCT05748925, which also lists 1 linked publication.
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 16 Apr 2025.