EUCTR2020-000695-38-SE进行中（未招募）1 期
Healthy diet rich in potassium containing fruits, vegetables and nuts to chronic kidney disease patients thought the use of sodium zirconium cyclosilicate: A Feasibility Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of signed informed consent prior to any study specific procedures;
- •2. Female and/or male patients;
- •3. Age between 18 to 85 years old;
- •4. Patients with chronic kidney disease under regular treatment at the outpatient clinic;
- •5. Glomerular filtration rate below 29 ml/min/1.73 m2 (stage 4 and 5 of the disease) and not on dialysis;
- •6. Plasma potassium = 5.1 mmol/L at baseline or patients using of sodium polystyrene sulfonate (SPS) 1 month prior to inclusion to decrease the potassium plasma levels who develops hyperkalemia after sodium polystyrene sulfonate is discontinued;
- •7. Negative pregnancy test (urine or serum) for female subjects of childbearing potential;
- •8. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of SZC to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Use of other potassium-lowering agent then SPS (loop-diuretics not included);
- •2. Participation in another clinical study with an investigational product during the last 3 months prior to inclusion;
- •3. Plasma potassium > 6.5 mmol/L;
- •4. Plasma potassium < 3.0 mmol/l at any visit;
- •5. Likely to start dialysis within 2 months according to the clinical judgment from the nephrologist;
- •6. Presence of inflammatory bowel syndrome;
- •7. Lack of fluence in the Swedish language;
- •8. Known hypersensitivity to SZC;
- •9. Known history of drug or alcohol abuse within 1 year of screening;
- •10. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding;
- •11. History of QT prolongation associated with other medications that required discontinuation of that medication;
- •12. Congenital long QT syndrome;
- •13. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted;
- •14. History of QT-prolongation: QTc(f) > 550 msec or uncontrolled atrial fibrillation.
研究者
相似试验
招募中
不适用
Dietary Potassium Liberalization in Pre-Dialysis PatientsChronic Kidney DiseaseHyperkalemiaNCT05090865University of Manitoba30
进行中（未招募）
4 期
Effect of potassium rich diet in patients with ulcerative colitisCTRI/2019/03/018217Dept of Gastroenterology
已完成
不适用
Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility StudyChronic Kidney Disease stage4Chronic Kidney Disease Stage 5HyperkalemiaNCT04207203Karolinska Institutet26
已完成
1 期
The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy PersonsHypertensionNCT00801034Erling Bjerregaard Pedersen25
已完成
不适用
Effect of a high potassium diet on endothelial functioCardiovascular diseaseACTRN12612000822886niversity of South Australia40