Protective effects of Febuxostat in early CKD: A Randomized Controlled Trial at a tertiary care centre
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Proportion of Patients showing more than 10 percent decline in eGFR in all 3 groups
研究概览
简要总结
Chronic Kidney Disease (CKD) is defined by reduced renal function (eGFR less than 90 mL/min/1.73 m²) or structural abnormalities lasting at least 3 months. While hyperuricemia is a potential modifiable risk factor for CKD progression, clinical evidence supporting urate-lowering therapy remains insufficient.
Febuxostat is a xanthine oxidase inhibitor primarily metabolized in the liver, making it safe for patients with low Glomerular Filtration Rates (GFR). Its effect on early kidney damage is currently not well-documented.
This randomized trial aims to determine if Febuxostat is non-inferior to a placebo in preventing eGFR decline among Indian patients with early CKD and asymptomatic hyperuricemia.
The study seeks to address gaps regarding the effects of dose modification and potential cardiovascular benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Asymptomatic Hyperuricemia, with CKD stage 3 and below, attending Geneal Medicine/ Nephrology OPD and IPD Patients with Uric acid concentration 7 to 10 mg/dl Patients willing to give consent.
排除标准
- •Patients with history of Gout.
- •Patients with Alanine or Aspartate aminotransferase level more than 3-fold the upper limit defined at the institution.
- •Patients on maintenance Hemodialysis therapy or Peritoneal dialysis.
- •Patients with Kidney transplantation.
- •Patients taking drugs like Thiazides or loop diuretics.
- •Pregnant or lactating females Patients having received Uricosuric drugs in preceding 3 months.
结局指标
主要结局
Proportion of Patients showing more than 10 percent decline in eGFR in all 3 groups
时间窗: Baseline to end of the study period
次要结局
- Changes in eGFR in the 3 groups(Baseline to end of the study period)
- Changes in Uric acid levels of the 3 groups(Baseline to end of the study period)
- Development of CKD stage 5(Baseline to end of the study period)
- Any Cardiovascular events(Baseline to end of the study period)
研究者
Mohammad Shadab Ansari
Jawaharlal Nehru Medical College