NL-OMON55005已完成4 期
Reversal Of Arterial Disease by modulating Magnesium And Phosphate - ROADMAP trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Aged between 18-80 years and a life expectancy >1 year
- •- CKD patient with an eGFR 15-50 ml/min/1.73m2
- •- Plasma magnesium concentration 0.5-1.4 mmol/L
- •- Plasma phosphate concentration 0.8-1.6 mmol/L
- •- Provide informed consent
排除标准
- •- Any phosphate binding therapy (with exception of calcium carbonate)
- •- Unwilling to discontinue over-the-counter magnesium supplementation (for the
- •study duration)
- •- Renal transplantation in medical history or expected transplantation within 6
- •- Prolongation of QTc interval of > 500 ms, 2nd or 3rd degree atrio-ventricular
- •block on ECG or
- •bradycardia (heart rate below 50 bpm on screenings ECG)
- •- Atrial fibrillation or atrial flutter at last clinical or screenings ECG
- •- Known unstable carotid plaques
- •- Endoprothesis of the aorta
- •- Hemochromatosis or other causes of iron overload, or hemoglobin > 10.5 mmol/L
- •- Chronic diarrhea or gastrointestinal absorption disorders (ao gastric bypass
- •surgery, partial resection of the small-intestines, Crohn disease etc).
- •- Chronic use of antibiotics
- •- Active malignancy
- •- Pregnancy or lactation
- •- Serious substance abuse
- •- Recurrent incompliance for medication intake or hospital visits, i.e. *no-
- •- No sufficient understanding of the Dutch or English language
- •- Inability to measure PWV or to take blood samples for any reason, inability
- •to swallow medication
研究者
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