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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a type of diabetes medication called an SGLT2 inhibitor (commonly used for blood sugar and kidney protection) can also help protect the kidneys in patients with lupus nephritis — a form of kidney disease caused by the autoimmune condition lupus. **You may be eligible if...** - You have been diagnosed with lupus nephritis (confirmed by kidney biopsy, Class III, IV, or V) - You have chronic kidney disease with reduced kidney function (eGFR between 15 and 60 mL/min) - Your lupus is currently stable and not in a flare (low disease activity score) - You are on a stable dose of a steroid called prednisolone **You may NOT be eligible if...** - Your lupus is currently in an active flare - Your kidney function is outside the required range - You have not had a kidney biopsy confirming lupus nephritis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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