NCT05704088

SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients

Completed Phase 4 Last updated 15 October 2024

What this trial tests

Phase 4 trial testing Dapagliflozin tablet in SGLT2 INHIBITORS in 100 participants. Completed in 8 January 2024.

Timeline

8 October 2022

Primary endpoint
8 January 2024

8 January 2024

Quick facts

Lead sponsor	Mansoura University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	100
Start date	8 October 2022
Primary completion	8 January 2024
Estimated completion	8 January 2024
Sites	1 location across Egypt

Drugs / interventions tested

• Dapagliflozin tablet
• placebo

Conditions studied

• SGLT2 INHIBITORS — all drugs for SGLT2 INHIBITORS →
• Lupus Nephritis — all drugs for Lupus Nephritis →
• BMD — all drugs for BMD →

Sponsor

Mansoura University

Who can join

18 and older, any sex, with SGLT2 INHIBITORS or Lupus Nephritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this Randomized, controlled trial in 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.

1\. The main questions it aims to answer are:

* Assess the role of sodium glucose co transporter 2 inhibitors (SGLT2i) in regression of ongoing kidney and cardiac diseases among diabetic or non-diabetic patients with lupus nephritis (LN) under different immunosuppressive therapies.
* Investigate the impact of SGLT2i on bone and mineral metabolism in these patients.

Participants 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.
* Control group: will be maintained on their medication.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Narrative Review of Immunomodulatory and Anti-inflammatory Effects of Sodium-Glucose Cotransporter 2 Inhibitors: Unveiling Novel Therapeutic Frontiers.
   Lee SA, Riella LV. · · 2024 · cited 29× · PMID 38899203 · DOI 10.1016/j.ekir.2024.02.1435
2. Leveraging Lymphatic System Targeting in Systemic Lupus Erythematosus for Improved Clinical Outcomes.
   Babalola KT, Arora M, Ganugula R, Agarwal SK, et al · · 2024 · cited 3× · PMID 38351070 · DOI 10.1124/pharmrev.123.000938
3. Global perspectives on lupus nephritis: a review of clinical trials and therapeutic innovations.
   Xu J, Zhang Y, Huang H, Cao Y. · · 2026 · PMID 42233033 · DOI 10.3389/fimmu.2026.1762892
4. SGLT2 inhibitors in autoimmune diseases: emerging therapeutic potential and clinical challenges.
   Luo T, Zhang L, Tu K, Li G, et al · · 2025 · PMID 40677716 · DOI 10.3389/fimmu.2025.1589341