NL-OMON53426尚未招募不适用
The role of skin sodium accumulation in chronic kidney disease - SKIN-CKD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria
- •1. Chronic kidney disease with an eGFR between 15 and 60 ml/min/1.73m2.
- •2. Stable diuretic and antihypertensive treatment in the 6 weeks prior to the
- •Additional inclusion criteria for the sodium excretion intervention
- •1. Office systolic blood pressure (SBP) >135 mmHg
排除标准
- •Exclusion criteria
- •1. Age <18 years.
- •2. An eGFR decline >5 ml/min/1.73m2 per year.
- •3. Proteinuria >3 grams/day.
- •4. Use of glucocorticoids with an equivalent of prednisolone >5mg/day
- •5. Use of or a calcineurin inhibitor.
- •6. Contra-indication for MRI i.e. metallic foreign body, claustrofobia
- •7. Cardiovascular event in the 3 months prior to the study
- •8. Patients with active infection and/or auto-immune diseases with involvement
- •of the lower extremities.
- •9. Presence of significant comorbidities (e.g. advanced malignancy, advanced
- •liver disease) with a life expectancy of less than 1 year.
- •Additional exclusion criteria for sodium intake intervention
- •1. Chronic use of NSAID
- •Additional exclusion criteria for sodium excretion intervention
- •1. Serum potassium concentration >5.0 mmol/l.
- •2. eGFR <30 ml/min/1.73m2
- •3. Uncontrolled hypertension (>180/100mmHg)
- •4. Contra-indication for drugs used during this study e.g. drug intolerance
- •(side effect, hyperkalaemia hypersensitivity to sulphonamides) and drug
- •interaction.
- •5. Chronic use of NSAID.
研究者
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