Outcome of Use of a Novel Modulator of Oxidative Phosphorylation on Kidney Function in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Decrease rate of GFR decline
研究概览
简要总结
Outcome of use of a novel Modulator of Oxidative Phosphorylation on kidney function in patients with Chronic Kidney Disease
详细描述
QRX-3 ( Eseronate ) is a formulated drug designed to supply and optimize NAD+ mitochondrial availability in order to target the loss of nephrons via renal fibrosis and tubular senescence of the kidney cells by enhancing the mitochondrial activity of these cells via the NAD/NAD+ redox pathway as well as reduce the presence of fibrogenic intracellular inflammatory markers . This novel drug therapy stabilized the intracellular oxidative phosphorylation process a pathway mechanism that is dysregulated or abnormal in the ongoing renal tubular cell injury and damage in chronic kidney disease.
In this study the investigators evaluate the effect of intervention with this novel drug therapy on a chronic kidney disease CKD population with slowly progressively declining renal function.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •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 > 20 % over last one year
- •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
Patient with progressive chronic kidney disease
GFR decline
干预措施: QRX-3 (Drug)
Patient with progressive chronic kidney disease
GFR decline
干预措施: Eseronate (Drug)
结局指标
主要结局
Decrease rate of GFR decline
时间窗: 6 months
Comparism of percentage and mean change in GFR with time
次要结局
- Effect on proteinuria with time(6 months)
研究者
Ebima Clifford Okundaye
Principal investigator
Neukidney Inc.