Role of QRX-3 a Novel NAD Modulator in Ambulatory Chronic Kidney Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- daily change in glomerular filtration rate by creatinine in mls/min
研究概览
简要总结
QRX-3, a new drug that stabilized the kidney renal tubular cell and increase the activity of NAD ( nicotinamide adenine dineuclotide )within the kidney cells; leading to decrease oxidative changes intracellularly, repair of renal tubular injury and restoration of optimized renal function above baseline , will be studied in patients with progressive chronic kidney disease over 12 months . The result of the change in renal function expressed as creatinine GFR (Glomerular filtration decline) over the treatment duration will be compared in the treatment group will be compared to control group without the medication during that same period .
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
- Double (Care Provider, Outcomes Assessor)
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
- •Patient with Chronic kidney disease stage 3-5
- •Estimated Glomerular function by MDRD of less than 60mls/min
- •Patients with declining renal function ( as measured by eGFR by MDRD )
- •Rate of decline of eGFR over the last one year of less than 20%
- •Negative Serology markers for CKD etiology
- •Provider perceived adherence to study follow- up
排除标准
- •Rapid rate of decline in kidney function of > 10 % over 3 months
- •Symptomatic renal failure
- •Presence of any suspected Acute renal failure superimposed
- •Presence of cast , hematuria, or abnormal urinalysis outside of simple UTI
- •No known reversible cause of renal decline
研究组 & 干预措施
Intervention group
QRX-3 drug given in addition to standard therapy for CKD
干预措施: QRX-3 (Drug)
结局指标
主要结局
daily change in glomerular filtration rate by creatinine in mls/min
时间窗: 12 months
mean change in glomerular filtration rate by creatinine in mls/min in one year compare to baseline at screening
次要结局
- change in proteinuria by mg/g(12 months)
研究者
Ebima Clifford Okundaye
Principal investigator
Neukidney Inc.