NCT06155604 SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease
| NCT ID | NCT06155604 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Hong Kong |
| Condition | Lupus Nephritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-01-04 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2023-01-04 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Patients with biopsy-proven Class III or IV or V LN according to the ISN/RPS 2003 classification 2. Patients with CKD (eGFR 15-60mL/min) 3. Patients in quiescent disease (defined as SLEDAI score \<4 with no points in the renal domain) 4. 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 Criteria: 1. Patients with biopsy-proven glomerulonephritis other than LN or hereditary kidney diseases 2. Patients with type 1 diabetes mellitus (DM) 3. Patients with stage 5 CKD or ESKD on renal replacement therapy 4. Patients with frequent urinary tract infections 5. Patients with history of ketoacidosis
Contact & Investigator
Desmond Yap, MD (HK)
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT06155604 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lupus Nephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06155604 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06155604 currently recruiting?
Yes, NCT06155604 is actively recruiting participants. Contact the research team at desmondy@hku.hk for enrollment information.
Where is the NCT06155604 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06155604 clinical trial?
NCT06155604 is sponsored by The University of Hong Kong. The principal investigator is Desmond Yap, MD (HK) at The University of Hong Kong. The trial plans to enroll 150 participants.
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