Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury
试验速览
- 阶段
- 2 期
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Incidence of acute kidney injury defined as any of the followings
研究概览
简要总结
Cisplatin is a potent chemotherapeutic agent, however, its nephrotoxicity manifested by acute kidney injury (AKI) often limits applicability. Dipeptidylpeptidase-4 (DPP4) inhibitors are well known to improve glucose intolerance by augmentation of endogenous glucagon like peptide (GLP-1) and glucose-dependent insulinotropic peptide (GIP). DPP4 inhibitor also has the potential anti-apoptotic and renoprotective effect in a mouse model of cisplatin-induced AKI. This is a single-center, randomized, double-blind, parallel-group, placebo-controlled, prospective study to investigate the renoprotective effect of DPP4 inhibitor on cisplatin-induced AKI. A total 182 patients, who are scheduled to treat with cisplatin, will be recruited and randomly assigned to either Gemigliptin or placebo groups. Subjects will take study drugs for 8 days starting from one day before cisplatin treatment. Serum creatinine (Cr) and estimated glomerular filtration rate (eGFR) will be measured at 7 days after cisplatin treatment.
详细描述
This study will investigate possible renoprotective effects of DPP4 inhibitor on cisplatin induced acute kidney injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •cancer patients treated with intravenous cisplatin
- •written consent
排除标准
- •Diabetes mellitus
- •Chronic kidney disease stage IV-V (eGFR < 30ml/min/1.73m2)
- •History of transplantation
- •History of acute kidney injury before randomization
- •Use of other nephrotoxic agents such as non steroidal anti-inflammatory drugs, aminoglycosides, colistin, vancomycin
- •Receiving contrast media during last 72 hours
- •Liver disease (bilirubin > 2 mg/dl, transaminase levels >2.5 times the upper limit normal)
- •Active infection
- •Patients with high risks of dehydration owing to poor oral intake
- •High blood pressure (> 180/110 mmHg despite antihypertensive medications)
- •Hypersensitivity to Gemigliptin or its excipients
- •Low compliance to Gemigliptin treatment
研究组 & 干预措施
Experimental: Gemigliptin and Cisplatin
Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
干预措施: Gemigliptin (Drug)
Experimental: Gemigliptin and Cisplatin
Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
干预措施: Cisplatin (Drug)
Control arm
Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
干预措施: Placebo (Drug)
Control arm
Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
干预措施: Cisplatin (Drug)
结局指标
主要结局
Incidence of acute kidney injury defined as any of the followings
时间窗: up to 7 days
* Increase in sCr by ≥ 0.3 mg/dl * Increase in sCr to ≥ 1.5 times baseline * Decrease in eGFR to ≥ 25% All subjects receive Gemigliptin or placebo at a total dose of 100mg (50mg twice a day) for 8 consecutive days, serum creatinine will be measured.
次要结局
- delta eGFR(up to 7 days)
- delta Cr(Time Frame: up to 7 days)
研究者
Ki Young Na
Professor
Seoul National University Bundang Hospital