Using SGLT2 inhibitors to treat lupus nephritis in patients with chronic kidney disease
A Randomized Controlled Trial on SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease
This study is testing if the medication dapagliflozin can improve kidney function in people with lupus nephritis and chronic kidney disease who are already receiving standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06155604 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of dapagliflozin, an SGLT2 inhibitor, in patients with lupus nephritis and chronic kidney disease. The study focuses on patients with biopsy-proven lupus nephritis who are experiencing stable disease and are on standard maintenance therapy. By evaluating the impact of dapagliflozin on renal outcomes, the trial aims to provide a novel therapeutic approach for managing chronic kidney disease in this patient population. The study will assess changes in kidney function and other health outcomes over the course of treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with biopsy-proven Class III, IV, or V lupus nephritis and chronic kidney disease with stable disease.
Not a fit: Patients with type 1 diabetes, stage 5 chronic kidney disease, or other forms of glomerulonephritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve kidney function and reduce the risk of end-stage kidney disease in lupus nephritis patients.
How similar studies have performed: Previous studies have shown promising results for SGLT2 inhibitors in chronic kidney disease, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Desmond Yap, MD (HK) — The University of Hong Kong
- Study coordinator: Desmond Yap, MD (HK)
- Email: desmondy@hku.hk
- Phone: 85222554385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.