SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease

Sponsor
The University of Hong Kong
Study ID
NCT06155604
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Dapagliflozin 10mg daily
  • Standard maintenance therapy — DRUG
    Prednisolone 5-7.5 mg daily alone or in combination with Mycophenolate mofetil (\<=1.5 g/D) or Azathioprine (\<=150 mg/D)

Study Details

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.

Key Dates

Start date
Jan 4, 2023
Status verified
Dec 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    standard maintenance therapy plus dapagliflozin 10 mg daily
  • Other: Control group
    standard maintenance therapy only

Primary Outcome Measure

eGFR reduction [ Time Frame: 24 months ]

Central Contacts

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