Effect of Dapagliflozin on Renal Outcomes and Bone Mineral Disease in Non-diabetic Chronic Kidney Disease Patients
Chronic Kidney Diseases, Bone Diseases, Metabolic
About this trial
This is an interventional prevention trial for Chronic Kidney Diseases focused on measuring CKD, Bone mineral disease, SGLT2i
Eligibility Criteria
Inclusion Criteria: Patients aged more than 18 year. CKD patient with eGFR from 25 to 75 ml/min/1.73m2 with no evidence of acute drop of the GFR in the last 3 months. Willing to sign informed consent. Exclusion Criteria: eGFR less than 25 ml/min per 1.73 m2. Medical history of chronic disease (diabetes mellitus, chronic liver and/or respiratory diseases). Patients with primary or secondary glomerulonephritis/ nephrotic syndrome (proteinuria ≥ 3.5 gm/day) and/or any evidence of active immunological/ collagen vascular disease. Inability to sign the study consent form or refusal to participate in the study. Evidence of urinary obstruction. Patients with evidence of volume depletion or receiving a combination of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBS).. Patients with current history of frequent hypotensive episodes or systolic blood pressure <100 mmHg. Patients with history of recurrent urinary tract infection and/or valvovaginitis Patients with ongoing active malignancy. Patients with any evidence of active infection including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and tuberculosis (TB). Current or previous organ transplantation, or expected to get a kidney transplant within 12 months. Patients who received any SGLT2i for more than 3 months in the past. Patients who are already on medications that may affect or interact with bone metabolism such as bisphosphonates, calcitonin, steroid, denosumab and estrogen during the last 6 months. Pregnant and/or lactating woman.
Sites / Locations
- Urology and Nephrology center, Mansoura University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Dapagliflozin group
Placebo group
Includes 50 patients, they will receive SGLT2i as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.
Includes 50 patients, they will receive placebo plus their medication.