The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- serum creatinine (SCr)
研究概览
简要总结
The goal of this clinical trial is to evaluate the protective effect of metformin on nephrotoxicity of cisplatin in patients with bladder cancer. The main questions it aims to answer are:
- To determine protective effect of metformin on structural and functional kidney injury caused by cisplatin in patients with bladder cancer.
- To evaluate the safety of combining cisplatin and metformin on patients with bladder cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-diabetic adults of age between 18 to
- •Chemotherapy naïve patients diagnosed with bladder cancer.
- •Patients with stable renal function: eGFR is above 60 ml/min/1.73 m2
排除标准
- •Patients with history of lactic acidosis.
- •Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, NSAIDs, aminoglycoside or vancomycin).
- •Unstable renal function (defined as an increase in serum creatinine of 0.3 mg/dL or greater suddenly in 48 hours according to the acute kidney injury network (AKIN) classification
- •Patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock).
- •Severe infection and sepsis.
- •Any infection requiring hospitalization.
- •Any infection leading to a need for oxygen, intubation, vasopressors or fluids to support blood pressure.
- •Alcohol intake.
- •Respiratory failure.
- •Severe hepatic impairment (Child-Pugh class C).
- •Patients with metastasis.
研究组 & 干预措施
Metformin
(39) patients taking metformin (500 mg twice daily) with cisplatin (70 mg/m2) and gemcitabine (1000 mg/m2) (GC) protocol
干预措施: Metformin Hydrochloride 500 MG (Drug)
结局指标
主要结局
serum creatinine (SCr)
时间窗: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity.
Human Neutrophil gelatinase-associated lipocalin (NGAL)
时间窗: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
Cystatin C
时间窗: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
Estimated glomerular filtration rate (eGFR)
时间窗: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
次要结局
- Blood pH(12 week)
- Blood Lactate Level(12 week)
- HbA1C(12 week)
- Body Mass Index(12 week)
- Body weight(12 week)
- FBG(12 week)
研究者
Samah Essam Saber Mahran
Principal Investigator
Cairo University