Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- DEXA of Wrist
研究概览
简要总结
Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones, glucose metabolism and kidney.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimate GFR <= 45 and >15 ml/min/1.73m2
排除标准
- •Previous chronic treatment with alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
- •bicarbonate level <20 or >25 mEq/L
- •New York Heart Association Class III or IV heart failure
- •Systolic blood pressure >180 mmHg
- •Initiation of ESRD treatment planned within 6 months
- •Kidney transplantation
- •Treatment with immunosuppressives within the last 3 months
研究组 & 干预措施
Sodium bicarbonate
0.4 mEq/kg/day ideal body weight to be taken once a day
干预措施: Sodium bicarbonate (Drug)
Placebo
placebo dosage/frequency equivalent to sodium bicarbonate
干预措施: Placebo (Drug)
结局指标
主要结局
DEXA of Wrist
时间窗: 2 year
The investigators will evaluate changes in bone mineral density at the wrist.
Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times
时间窗: 2 year
Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups.
次要结局
- Quality of Life - Physical Function Domain(2 year)
- Estimated GFR(2 year)
- Hand-grip Strength(2 year)
研究者
Michal L. Melamed
Associate Professor
Albert Einstein College of Medicine