Comparison of the Effects on Renal Function of Lumiracoxib and Diclofenac in Patients With Chronic Kidney Failure K/DOQI Stage III at the HCSAE PEMEX
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in GFR
研究概览
简要总结
The purpose of this study is to determine whether the use of lumiracoxib in this particular population is associated with a decrease in glomerular filtration rate (GFR) compared to diclofenac; and to compare the magnitude of such impairment, if any, associated with use of lumiracoxib and diclofenac.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic joint pain, requiring analgesia
- •pre-existing chronic kidney injury, stage K/DOQI III (GFR 30 - 59 ml/min)
- •in a stable phase of CKD (i.e. not AKI, not hospitalized)
- •without contraindications for NSAID therapy
- •who have signed an informed consent
排除标准
- •having received any NSAID 2 weeks prior to study start
- •history of / actual PUD
- •patients with ESRD (K/DOQI IV, V or replacement therapy)
- •history of hypersensitivity or allergies to any of the treatments
- •history of / actual GI bleeding
- •with impaired liver function tests
- •using ACEI / ARB
研究组 & 干预措施
Lumiracoxib group
Patients in this group will receive a standard fixed dose of lumiracoxib PO (200 mg/day) for a period of maximum 10 days, but no shorter than 7 days.
干预措施: Lumiracoxib (Drug)
Diclofenac group
Patients in this group will receive a standard fixed dose of diclofenac PO (100 mg/day) for a period no longer than 10 days but no shorter than 7 days.
干预措施: Diclofenac (Drug)
结局指标
主要结局
Change in GFR
时间窗: Change in GFR will be measured at start of treatment (baseline) and again at the end of treatment (max. 10 days) for each patient
Magnitude of change in GFR (ml / min) as measured by creatinine clearance in urine over 24 hours, considering the initial and final value at the end of the study. Creatinine clearance will be measured twice: initially, prior to the first dose of medication (baseline), and again at the end of treatment (ie. 10 days after starting dose).
次要结局
- Use of rescue medication(Use of rescue medication will be assessed at the end of treatment (ie. 10 days after first dose))
- Subjective improvement in pain(Pain will be assessed with VAS at the start of treatment and again at the end of treatment (ie. 10 days after first dose))
研究者
Carlos Molina-Calzada
Resident - Internal Medicine Department
Hospital Central Sur de Pemex