Preservation of Kidney Function in Kidney Transplant Recipients by Alkali Therapy (Preserve-Transplant Study): a Multi-center Randomized Single-blind Placebo- Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- eGFR
研究概览
简要总结
The aim of this study is to test if alkali treatment will preserve kidney graft function and diminish the progression of chronic kidney disease in renal transplant patients. Additionally the underlying mechanisms of nephrotoxicity of metabolic acidosis will be investigated in this cohort.
This study is a multi-center, prospective, randomized, single-blind (patient), placebo-controlled interventional trial to test the superiority of alkali treatment in comparison to placebo on preservation of kidney function in 300 kidney transplant recipients. The duration of the study will be 2 years for the individual participant. The patients will be randomized into 2 arms: intervention arm (sodium hydrogen carbonate, product: Nephrotrans®) and placebo arm (placebo comparator).
Several studies in CKD (chronic kidney disease) patients have shown that alkali therapy slows progression of CKD.
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
- Single (Participant)
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
- •Informed consent as documented by signature
- •age ≥ 18 years and able to give informed consent
- •≥ 12 months after renal transplantation
- •stable clinical condition
- •stable graft function over the last 3 months (creatinine changes ± 15%)
- •eGFR between 15-89 ml/min/1.73 m2
- •serum bicarbonate ≤ 22 mmol/l within the last 6 months
排除标准
- •uncontrolled hypertension or use of > 4 antihypertensive agents
- •uncontrolled heart failure
- •serum potassium < 3.0 mmol/l
- •serum sodium > 150 mmol/l
- •use of alkali in the preceding 4 weeks
- •use of mineralocorticoid antagonists, topiramate, carbo anhydrase inhibitors or any drugs with similar effects
- •history of noncompliance with clinic visits
- •hereditary fructose intolerance
- •known hypersensitivity or allergy to the drug used in this study or to peanut, sorbitol, and soy
- •pregnancy or breastfeeding
- •intention to become pregnant during the course of the study
- •lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- •please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- •suspected drug or alcohol abuse
- •inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •enrolment of the investigator, his/her family members, employees and other dependent persons
研究组 & 干预措施
Placebo
Patients will receive Placebo.
干预措施: Placebo (Other)
Verum
Patients will receive Nephrotrans.
干预措施: Nephrotrans (Drug)
结局指标
主要结局
eGFR
时间窗: 2 years
Change in renal function by assessing the change in eGFR over 2 years from baseline. eGFR will be determined based on the CKD-EPI creatinine equation.
次要结局
未报告次要终点