Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Measuring some of important in-body anthropometric measures
研究概览
简要总结
This study aims to assess the effect of obesity on therapeutic response and safety of cyclosporine trough level in nephrotic syndrome patients and calculating a suitable weight-based dose.
详细描述
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
- Agreement from all participants should be taken in this clinical study by assigning an informed consent.
- Nephrotic diseased patients,will be recruited from Alexandria main university hospital (AMUH).
- The 74 participants will be non-randomly assigned into 2 groups.
- The control group is non-obese nephrotic patients with BMI <25 kg/m2 will receive receive Cyclosporine capsule with conventional initial dose 3 mg/kg/day using actual weight.
- The Case interventional group is Obese nephrotic patients with BMI> 25kg/m2 will receive Cyclosporine capsule with the best weight based dose to achieve the targeted therapeutic trough level and targeted urinary protein/ creatinine ratio.
- All patients will be subjected to :
- First visit: Full patient history, anthropometrics (weight, hight, BMI, fat %, water %, muscles% and clinical examination. Calculate the initial cyclosporine dose 3mg/kg/day in 2 divided doses based on actual weight.
- Second visit after one month: blood sample withdrawal for measuring trough level, lipid profile and thyroid profile, urinary sample to measure uPCR If patients don't reach to targeted therapeutic trough level and targeted urinary protein/ creatinine ratio,re-modifying the dose and repeat the labs after another one month in third visit.
- Finally find the best weight can be used to achieve the targeted therapeutic trough level and targeted urinary protein/ creatinine ratio, and its relation with fat content and lipid profile
- The appropriate Statistical tests will be hold according to study design and parameters (parametric and non-parametric) to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Obese and overweight Nephrotic syndrome adult patients receiving Cyclosporine for more than one month with prednisolone. (BMI>25 kg/m2)
- •Normal or underweight individuals Nephrotic syndrome adult patients receiving Cyclosporine for more than one month with prednisolone. (serving as control group)
排除标准
- •Hepatic patients liver cirrhosis (moderate to severe liver impairment)
- •Cancer patients,
- •Pregnant and lactating female patients
研究组 & 干预措施
Obese nephrotic patients with BMI>25 kg/m2
Nephrotic obese patients receive Cyclosporine capsule initially according to weight-based dose then modifying the dose according to targeted therapeutic level.
To determine the best weight can be used to get the targeted therapeutic level. Correlate with the lipid profile, fat percentage and other anthropometric measures.
干预措施: Cyclosporine Capsule (Drug)
Non obese nephrotic patients with BMI<25 kg/m2
Nephrotic non-obese patients receive Cyclosporine capsule initially according to weight-based dose then modified dose according to targeted therapeutic level.
干预措施: Cyclosporine Capsule (Drug)
结局指标
主要结局
Measuring some of important in-body anthropometric measures
时间窗: Day 1
Measuring anthropometric measures as;body fat percentage, body water percentage and muscle percentage content at base line of starting the Cyclosporine regimen.
Measuring the height as one of anthropometric measures
时间窗: Day 1
Measuring anthropometric measures as;height in metres at base line of starting the Cyclosporine regimen.
Measuring the BMI as one of anthropometric measures
时间窗: Day 1
Measuring anthropometric measures as; BMI (body mass index) in kilograms/meter\^2 at base line of starting the Cyclosporine regimen.
Cyclosporine level concentration and its correlation to anthropometric measures
时间窗: 1 month
Measuring of Cyclosporine level in whole blood after one month of starting the drug
Determine a suitable weight-based dose for obese patients
时间窗: 1 month
Modifying the Cyclosporine dose according to measured trough level
Measuring the weight as one of anthropometric measures
时间窗: Day 1
Measuring anthropometric measures as; weight in kilograms at base line of starting the Cyclosporine regimen.
次要结局
- Assessment of kidney functions as clearance estimation(1 month)
- Assessment of kidney functions as urinary protein release(1 month)
- Lipid profile assessment(1 month)
- Thyroid function assessment(1 month)
- Covid-19 vaccine status assessment(Day 1)
- Assessment of kidney functions(1 month)