SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease
Recruiting
Phase 2Interventional Study
Lupus NephritisChronic Kidney Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
The University of Hong Kong · Other
Who this trial is looking for
This trial is looking for patients with lupus nephritis and chronic kidney disease (CKD) to see how a medication called an SGLT2 inhibitor affects kidney health. Participants will be monitored for side effects and changes in their condition.
Are You a Good Fit for This Trial?
Must be takingPrednisolone
You may be able to join if
I have been diagnosed with lupus nephritis
I have chronic kidney disease
I am stable with my disease
I have been taking a stable dose of prednisolone
I may also be taking MMF or AZA
You may not be able to join if
I have been diagnosed with another type of kidney disease
I have type 1 diabetes
I am on dialysis or have end-stage kidney disease
I have frequent urinary tract infections
I have a history of ketoacidosis
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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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 prednisol…
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
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