RecruitingPhase 2NCT06155604

SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease

A Randomized Controlled Trial on SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease


Sponsor

The University of Hong Kong

Enrollment

150 participants

Start Date

Jan 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Lupus nephritis (LN) is a common manifestation in patients with systemic lupus erythematosus (SLE), and is an important cause of acute kidney injury and chronic kidney disease (CKD). Although the standard-of-care treatments for active severe LN are effective, a substantial proportion of LN patients still develop CKD and eventually end-stage kidney disease (ESKD). Cardiovascular complications are common and is a leading cause of death in SLE and LN patients. It is well recognized that LN patients had multiple risk factors for cardiovascular complications such as diabetes mellitus (DM), dyslipidaemia and vascular inflammation. Sodium-glucose co-transporter 2 (SGLT2) inhibitor are initially developed as an oral anti-diabetic agent and has shown to be effective in glycaemic control, has benefits in lipid metabolism, cardiovascular and renal outcomes, and also well tolerated by patients. Various trials have also demonstrated the benefits of SGLT2 inhibitor in the reduction of CKD, ESKD, and renal or cardiovascular death. However, the effect of SGLT2 inhibitor in LN remains unclear. The purpose of this study is to investigate the effect of SGLT2 on renal outcomes in LN patients with CKD, as well as the side effects, metabolic profiles, immunological functions and disease stability.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Patients with biopsy-proven Class III or IV or V LN according to the ISN/RPS 2003 classification
  • Patients with CKD (eGFR 15-60mL/min)
  • Patients in quiescent disease (defined as SLEDAI score \<4 with no points in the renal domain)
  • Patients on a stable dose of prednisolone (PRED 5-7.5 mg/D) alone or in combination with MMF (\<=1.5 g/D) or AZA (\<=150 mg/D) in the past 3 months

Exclusion Criteria5

  • Patients with biopsy-proven glomerulonephritis other than LN or hereditary kidney diseases
  • Patients with type 1 diabetes mellitus (DM)
  • Patients with stage 5 CKD or ESKD on renal replacement therapy
  • Patients with frequent urinary tract infections
  • Patients with history of ketoacidosis

Interventions

DRUGDapagliflozin 10mg Tab

Dapagliflozin 10mg daily

DRUGStandard maintenance therapy

Prednisolone 5-7.5 mg daily alone or in combination with Mycophenolate mofetil (\<=1.5 g/D) or Azathioprine (\<=150 mg/D)


Locations(1)

Queen Mary Hospital

Hong Kong, Hong Kong

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NCT06155604


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