Assessment of Safety and Efficacy of SGLT2is Among LN Patients

NCT06113900 | Unknown Phase 1

• 1 other identifier: SGLT2I among LN patients
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (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.

  6 months

Study Arms (2)

Drug as Dapagliflozin 10 mg orally for 6 months is given

EXPERIMENTAL

25 lupus nephritis patients will receive SGLT2is as dapagliflozin 10mg beside there usual treatment of lupus for 6 months

Drug: Dapagliflozin 10mg Tab orally once daily

On there conventional lupus nephritis treatment

NO INTERVENTION

25 lupus nephritis patients didn't receive SGLT2i and continue on their conventional lupus nephritis treatment

Interventions

Dapagliflozin 10mg Tab orally once daily DRUG

Sodium glucose co-transporter 2 inhibitors

Also known as: Empagliflozin 10 mg tab orally once daily

Drug as Dapagliflozin 10 mg orally for 6 months is given

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Alexandria, Egypt

Location

Related Publications (7)

• 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.

  PMID: 35026193 BACKGROUND

• 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.

  PMID: 35613023 BACKGROUND

• Gounden V, Bhatt H, Jialal I. Renal Function Tests. 2024 Jul 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507821/

  PMID: 29939598 BACKGROUND

• 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.

  PMID: 37258468 BACKGROUND

• 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.

  PMID: 36430417 BACKGROUND

• 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.

  PMID: 37017254 BACKGROUND

• 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.

  PMID: 38334499 DERIVED

MeSH Terms

Conditions

Lupus Nephritis

Interventions

dapagliflozin; empagliflozin

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Howaida Al-Shennawi, Professor

  Professor of internal medicine and Nephrology

  PRINCIPAL INVESTIGATOR

• Cherry Kamel, Professor

  Professor of internal medicine and Nephrology

  STUDY DIRECTOR

Central Study Contacts

Marwa Ahmed Waly, MD

CONTACT

01288264247; Dr.marwa_waly@outlook.com

Marwa Abdel Samie, Lecturer

CONTACT

01278064363

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nephrology Department

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: November 2, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 30, 2025
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

EG (1)