Effect of Sodium-Glucose Co-transporter 2 Inhibitors on Kidney Disease Progression and Bone Mineral Metabolism in Non-diabetic Patients With Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effect of dapagliflozin on CKD progression
研究概览
简要总结
It is a randomized controlled trial in which 100 non diabetic chronic kidney disease (CKD) patient is being participated.
Their estimated glomerular filtration rate (eGFR) between 25-75 ml/min/1.73 m2.
Participants will be randomized into two groups:
- Study group: includes 50 patients, they will receive Sodium glucose co-transporter 2 inhibitor (SGLT2i) as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.
- Control group: includes 50 patients, they will receive placebo their medication.
The investigators will follow up all patients for 12 months and compare their results.
This study aims to:
- Assess SGLT2i role in delaying the progression of ongoing chronic kidney disease.
- Study the impact of SGLT2i on bone and mineral metabolism in this patients' population.
详细描述
All patients have been recruited from the renal clinic of Nephrology and transplantation unit. The entire study will be conducted at Urology and Nephrology center in Mansoura University.
Study design and sample size:
• Sample size: Was calculated based on previous research by (DAPA-CKD) study using G. power program with α error 0.05 and power 80% and it was equal to approximately 98 patients.
Type of the study: Randomized, controlled trial.
Patient's enrollment: 100 patients with non-diabetic CKD with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2 will be randomized into two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •eGFR less than 25 ml/min per 1.73 m
- •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.
研究组 & 干预措施
Placebo group
Includes 50 patients, they will receive placebo plus their medication.
干预措施: Placebo (Drug)
Dapagliflozin group
Includes 50 patients, they will receive SGLT2i as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.
干预措施: Dapagliflozin 10mg Tab (Drug)
结局指标
主要结局
Effect of dapagliflozin on CKD progression
时间窗: 1 year
effect of Dapagliflozin on eGFR (ml/min)
Effect of dapagliflozin on Bone
时间窗: 1 year
effect on serum levels of bone turnover markers measured by ELISA
Effect of dapagliflozin on minerals
时间窗: 1 year
effect of Dapagliflozin on calcium, phosphorus and magnesium
Effect of dapagliflozin on BMD
时间窗: 1 year
assess Bone mineral disease (BMD) by using quantitative CT (QCT)
次要结局
- Effect of dapagliflozin on blood pressure(1 year)
研究者
Mohamed Mohsen Elshayeb
Nephrology specialist at urology and nephrology center (principal investigator)
Mansoura University