Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06155604

SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease

Led by The University of Hong Kong · Updated on 2024-12-16

150

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with biopsy-proven Class III, IV, or V lupus nephritis according to ISN/RPS 2003 classification
  • Patients with chronic kidney disease with eGFR between 15 and 60 mL/min
  • Patients with quiescent lupus nephritis defined as SLEDAI score less than 4 and no renal activity
  • Patients on stable prednisolone dosage (5-7.5 mg daily) alone or combined with mycophenolate mofetil (up to 1.5 g daily) or azathioprine (up to 150 mg daily) for at least 3 months
Not Eligible

You will not qualify if you...

  • Patients with kidney diseases other than lupus nephritis confirmed by biopsy or hereditary kidney diseases
  • Patients diagnosed with type 1 diabetes mellitus
  • Patients with stage 5 chronic kidney disease or end-stage kidney disease on renal replacement therapy
  • Patients with frequent urinary tract infections
  • Patients with history of diabetic ketoacidosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Queen Mary Hospital

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

D

Desmond Yap, MD (HK)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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