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Lupus NephritisPhase 1/2NCT06113900

Assessment of Safety and Efficacy of SGLT2is Among LN Patients

A Phase 1/2 study testing Dapagliflozin 10mg Tab orally once daily in people with Lupus Nephritis, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to assess the safety and efficacy of SGLT2is among LN patients. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Lupus Nephritis
What is being tested?
Dapagliflozin 10mg Tab orally once daily
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Dec 2023to 30 Jan 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients aged more than 18 year.
  • Patients with confirmed SLE according to EULAR/ACR classification criteria.
  • Patients with LN ( persistent proteinuria > 2 gm per day or greater than 3+ by dipstick, and/or cellular casts including red cell, hemoglobin, granular, tubular or mixed \& "active urinary sediment" (>5 RBC/hpf, >5 WBC/hpf in the absence of infection, or cellular casts limited to RBC or WBC casts )
  • Patient with e GFR > 25 ml/min/1.73m2 by CKD-EPI equation.

Who cannot join

  • Patients with an allergy or intolerance to Dapagliflozin or any prior SGLT2i exposure within 1 month before screening.
  • Medical history of chronic disease (Severe respiratory distress, gastrointestinal tract lesions \& chronic liver disease)
  • Patients with recurrent genitourinary infections.
  • Patient with proteinuria < 2gm.
  • Patient who show response to immune therapy in proteinuria reduction > 50%.
  • Patient with Lupus in induction phase.
Show all 12Show fewer
  • Patient on steroids > 30 mg daily dose.
  • Patients with diabetes mellitus.
  • Patients with severe infection requiring antibiotics within 1 month before screening.
  • Patients with malignant diseases.
  • Pregnant or breast-feeding women.
  • Patients with eGFR < 25 ml/min/1.73m2 or undergoing dialysis therapy

Trial locations and contacts

1 site in 1 country.

Marwa Ahmed Waly, MD contact

01288264247

Dr.marwa_waly@outlook.com

Marwa Abdel Samie, Lecturer contact

01278064363

Egypt1 site

  • Ain Shams University

    Alexandria

    Howida Al Shennawi, Professor, 01223429592

Other trials in Egypt

About this study

Official title: Assessment of Safety and Efficacy of Sodium Glucose Co-transporter 2 Inhibitors Among Lupus Nephritis Patients

The aim of this study is to assess the safety and efficacy of SGLT2is among LN patients.

Read the detailed description

SLE is a chronic debilitating autoimmune disorder that involves multiple organ systems either simultaneously or sequentially with relapsing and remitting course. The word 'Lupus' is a Latin term which means wolf.

Lupus nephritis (LN) is one of the common complications in patients with SLE and influences overall outcome of these patients. About two-thirds of patients with SLE have renal disease at some stage which is a leading cause of mortality in these patients.

Manifestations of LN vary from asymptomatic urinary abnormalities to rapidly progressive crescentic glomerulonephritis to end-stage renal disease (ESRD).

Recently, metabolic modulation approach has become a hot spot in the management of SLE. Increased glucose metabolism in immune cells has been reported in patients with SLE.

Repurposing metformin, an old anti diabetic drug, has the potential to reduce the risk of lupus flare in randomized controlled trials. A recent crossover study implied that peroxisome proliferator-activated receptor-gamma agonists might decrease cardiovascular risk in patients with SLE.

Dapagliflozin, SGLT2i, is a new therapy for type 2 diabetes. The Dapagliflozin mode of action is to reduce glucose reabsorption in the epithelial cells of the proximal renal tubule of the kidney, which results in decreased blood glucose and glycated hemoglobin levels.

Strikingly, four cardiovascular outcome trials demonstrated that treatment with SGLT2is (empagliflozin, canagliflozin and dapagliflozin) in patients with type 2 diabetes had prominent effects on slowing the decline rate of eGFR and decreasing albuminuria, as well as a significant reduction in cardiovascular events.

Furthermore, the nephroprotective efficacy of SGLT2is was extended to non-diabetic CKD, such as IgA nephropathy.

The net gain of SGLT2 inhibition is to reduce renal workload and to modulate weight loss and blood pressure.

The paradigm for CKD and congestive heart failure management has been shifted accordingly

Interestingly, all researchers have reported that SGLT2is could block lipopolysaccharide-induced and NLRP3-mediated inflammatory responses and regulate macrophage polarization via interplay with mammalian target of rapamycin (mTOR) and AMP-activated protein kinase pathway thereby, SGLT2is might further contribute to reducing inflammation, modulating endothelial dysfunction and decelerating atherosclerosis which are all relevant to the pathophysiology of SLE.

Here, the investigators initiated this study aiming to assess the safety and efficacy of dapagliflozin among patients with LN.

Conditions
Lupus Nephritis
Being tested
Dapagliflozin 10mg Tab orally once daily
Medical subject headings
Lupus Nephritis

What participants receive

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

  • Dapagliflozin 10mg Tab orally once dailyDrug

    Also called Empagliflozin 10 mg tab orally once daily

    Sodium glucose co-transporter 2 inhibitors

Study groups in NCT06113900
Study groupRoleWhat they receive
Drug as Dapagliflozin 10 mg orally for 6 months is givenExperimental25 lupus nephritis patients will receive SGLT2is as dapagliflozin 10mg beside there usual treatment of lupus for 6 months
Receives: Drug: Dapagliflozin 10mg Tab orally once daily
On there conventional lupus nephritis treatmentNo intervention25 lupus nephritis patients didn't receive SGLT2i and continue on their conventional lupus nephritis treatment

What is being measured

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

  1. Renal Function Tests:

    1. Measurement of serum urea level in mg/dl at 3 month's interval, that is, at 0, 3 and 6 months.
    2. Measurement of serum creatinine level in mg/dl at 3 month's interval, that is, at 0, 3 and 6 months.
    3. Measurement of serum uric acid level in mg/dl at 3 month's interval, that is, at 0, 3 and 6 months.

    Measured: 6 months

Timeline

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

  1. First posted2 Nov 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion30 Jan 2025 (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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06113900
Sponsor's protocol ID
SGLT2I among LN patients
Status last verified
Oct 2023
First submitted
20 Sep 2023
Last updated
2 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Abdollahi E, Keyhanfar F, Delbandi AA, Falak R, Hajimiresmaiel SJ, Shafiei M. Dapagliflozin exerts anti-inflammatory effects via inhibition of LPS-induced TLR-4 overexpression and NF-kappaB activation in human endothelial cells and differentiated macrophages. Eur J Pharmacol. 2022 Mar 5;918:174715. doi: 10.1016/j.ejphar.2021.174715. Epub 2022 Jan 11.

    PubMed 35026193

  • Braunwald E. Gliflozins in the Management of Cardiovascular Disease. N Engl J Med. 2022 May 26;386(21):2024-2034. doi: 10.1056/NEJMra2115011. No abstract available.

    PubMed 35613023

  • Gounden V, Bhatt H, Jialal I. Renal Function Tests. 2024 Jul 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507821/

    PubMed 29939598

  • Ma Y, Zhao Q, Peng H, Nalisa DL, Shan P, Jiang H. SGLT2i in Patients with Type 1 Diabetes: Benefits, Risks, and Preventive Strategies. Front Biosci (Landmark Ed). 2023 May 22;28(5):98. doi: 10.31083/j.fbl2805098.

    PubMed 37258468

  • Parodis I, Gomez A, Lindblom J, Chow JW, Sjowall C, Sciascia S, Gatto M. B Cell Kinetics upon Therapy Commencement for Active Extrarenal Systemic Lupus Erythematosus in Relation to Development of Renal Flares: Results from Three Phase III Clinical Trials of Belimumab. Int J Mol Sci. 2022 Nov 11;23(22):13941. doi: 10.3390/ijms232213941.

    PubMed 36430417

  • Sada K, Kurita N, Noma H, Matsuki T, Quasny H, Levy RA, Jones-Leone AR, Gairy K, Yajima N. MOONLIGHT study: the design of a comparative study of the effectiveness of belimumab in patients with a history of lupus nephritis from the post-Marketed effectiveness of belimumab cOhOrt and JapaN Lupus NatIonwide reGistry (LUNA) coHorT. Lupus Sci Med. 2022 Sep;9(1):e000746. doi: 10.1136/lupus-2022-000746.

    PubMed 37017254

  • Desai SB, Ahdoot R, Malik F, Obert M, Hanna R. New guidelines and therapeutic updates for the management of lupus nephritis. Curr Opin Nephrol Hypertens. 2024 May 1;33(3):344-353. doi: 10.1097/MNH.0000000000000969. Epub 2024 Feb 9.

    PubMed 38334499

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dapagliflozin 10mg Tab orally once daily in people with Lupus Nephritis, run by Ain Shams 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Marwa Ahmed Waly, MD (01288264247, Dr.marwa_waly@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Renal Function Tests: (time frame: 6 months). 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 NCT06113900, which also lists 7 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 2 Nov 2023.

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