The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Propensity of serum for calcification
研究概览
简要总结
This is a single-center, prospective, open-label, randomized, cross-over study.
详细描述
The primary hypothesis (H1) is that the T50 value will change between wash-out and high-dose (3000mg/d) sodium bicarbonate (Nephrotrans®) substitution.
The 0-hypothesis (H0) is that substitution of 3000 mg/d sodium bicarbonate (Nephrotrans®) has no effect on T50-values as compared to wash-out-phase.
Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between.
Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between. The study will start with an initial run-in wash-out phase, where all sodium bicarbonate or other alkalizing treatment taken by the patient as standard of care will be discontinued. Consequently, there will be a sodium bicarbonate treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another sodium bicarbonate treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 ±3 days of duration. Patients will be followed up to 12weeks after randomization until the last study visit of the final wash-out phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adults ≥ 18 years old
- •Prevalent (≥ 6 months after kidney transplantation) kidney transplant recipients
- •eGFR (CKD-EPI formula) between 10 and 50 ml/min/1.73 m²
- •Patient has provided informed consent prior to initiation of any study related procedure
排除标准
- •Allergy to sodium bicarbonate or any component of Nephrotrans®, namely soy or peanuts (reported cross-reactivity to peanuts has been reported in patients with soy-allergy).
- •Unstable clinical condition (e.g. uncontrolled heart failure, clinical uremia, uncontrolled hypertension, impending initiation of dialysis treatment…) as judged by the recruiting physician
- •Pregnant and nursing (lactating) women
- •Unwillingness to discontinue current medication with sodium bicarbonate
- •Unwillingness to discontinue antacids containing aluminum, calcium carbonate, magnesium, lactate, citrate, bicarbonate or mixtures thereof
研究组 & 干预措施
Low dose sodium bicarbonate
Low dose 1500 mg sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take one capsule with breakfast, one with lunch and one with dinner (schedule 1-1-1).
干预措施: Low dose sodium bicarbonate (Drug)
High Dose sodium bicarbonate
High dose 3000 mg of sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take two capsules with breakfast, two with lunch and two with dinner (schedule 2-2-2).
干预措施: High dose sodium bicarbonate (Drug)
结局指标
主要结局
Propensity of serum for calcification
时间窗: 12 weeks
The primary outcome is change in the mean T50 values between different study phases (treatment vs. control).
次要结局
- Serum bicarbonate levels(12 weeks)
研究者
Prim. Priv. Doz. Dr. Daniel Cejka
Head of Nephrology
Elisabethinen Hospital