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The goal of this Randomized, controlled trial in 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
1. The main questions it aims to answer are:
Participants will be randomized into two groups :
Study sitting: Nephrology and renal transplant unit at urology and nephrology center in Mansoura University.
Study design and sample size:
Randomized, controlled trial that will include 100 patients with Lupus nephritis (LN) with an estimated glomerular filtration rate of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
Control group: will be maintained on their medication.
Study Protocol:
Patients in the study group will treated with dapagliflozin initiated at a total daily dosage of 10 mg once daily.
Methods:
The following data will be gathered and evaluated for all patients:
I-before intervention:
Patients of both groups will be subjected to full history taking including duration of LN and drug history and routine clinical examination including blood pressure and BMI measurements.
Laboratory investigations:
Serum creatinine, Creatinine clearance. 24 hour urine protein, urine protein/creatinine ratio. Urine analysis. HBA1c. hemoglobin (HGB). Uric acid and lipid profile. Lupus serology. immunoreactive parathyroid hormone (iPTH). Vitamin D level. Fibroblast growth factor 23 level. bone turnover markers : bone specific alkaline phosphates propeptides of type 1 procollagen tartrate resistant acid phosphatase 5b sclerostin level
Radiological investigation:
Quantitative computed tomography: to detect bone and mineral density (BMD). Cardiovascular assessment: Echocardiography and vascular calcification incidence (NCCT model) : for detection of coronary calcification.
II-after intervention:
All patients will be evaluated monthly regarding:
Regular measurement of blood pressure each visit.
Laboratory investigations:
Serum creatinine, creatinine clearance. 24 hour proteinuria, protein/creatinine ratio. Fasting, random and postprandial glucose levels. calcineurin inhibitors (CNI) trough level if used. Urine analysis. HGB level. Uric acid, lipid profile. Lupus serology.
All patients will be evaluated every 3 month regarding:
All patients will be evaluated at 12 month regarding:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Active Comparator | Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one year. |
|
| control group | Placebo Comparator | Control group: will receive placebo as add on drug once daily with or without food for one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin tablet | Drug | randomized control trial, study group will receive dapagliflozin tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| effect of dapagliflozin on renal function | Effect of dapagliflozin on eGFR (ml/ min). | 1 year |
| effect of dapagliflozin on kidney function | Effect of dapagliflozin on s.creatinine (mg/dl). | 1 year |
| effect of dapagliflozin on BMD | Effect of dapagliflozin on osteoporosis using Qct | 1 year |
| effect of dapagliflozin on minerals | Effect of dapagliflozin on serum calcium and phosphorus (mg/dl) | 1 year |
| effect of dapagliflozin on Bone | Effect of dapagliflozin on bone turnover markers (ng/dl) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| effect of dapagliflozin on blood pressure | measuring systolic and diastolic blood pressure mmgh before and after intervention | 1 year |
| effect of dapagliflozin on body weight | assessing body weight in kg before and after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology and Nephrology Center | Al Mansurah | 35511 | Egypt |
all individual participant data (IPD) that underlie results in a publication
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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Randomized, controlled trial that will include 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.
The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
Control group: will be maintained on their medication.
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| placebo | Drug | randomized control trial, control group will receive placebo tablets |
|
| 1 year |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |