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RECRUITING
NCT06155604
PHASE2

SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-01-04

Completion Date

2026-12-31

Last Updated

2024-12-16

Healthy Volunteers

No

Interventions

DRUG

Dapagliflozin 10mg Tab

Dapagliflozin 10mg daily

DRUG

Standard 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