NL-OMON41487已完成4 期
SoFT - Sevelamer on FGF23 Trial - A clinical trial assessing the quantitative effect of phosphate binding therapy on FGF23. - SoFT - effect of Sevelamer On FGF23 Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
- •1. Patients with stage II-IV CKD or with stage I CKD with an albumin-to-creatinine ratio in a first morning spot urine specimen of 100 mg/mmol, while on ACE-inhibition or on ARBs.
- •2. Serum phosphate levels between 0.80-1.45 mmol/l.
- •3. Not taking any phosphate binder therapy.
- •4. Providing informed consent.
排除标准
- •1. Patients taking medications or having concomitant illnesses likely to confound endpoint assessments (e.g. phosphate binder therapy, antiarrhythmic agents or anticonvulsants).
- •2. Patients with albumin-to-creatinine ratio > 100 mg/mmol not receiving ACE-inhibitors or ARB.
- •3. Women, who are pregnant or breastfeeding.
- •4. Change in vitamin D dose 4 weeks prior to baseline.
- •5. History of parathyroidectomy.
- •6. Hyperparathyroidism (e.g. PTH levels >2.5 upper normal)
- •7. History of arrhythmia or seizures.
- •8. Patients who have bowel obstruction, or malabsorption.
- •9. Posttransplant patients.
- •10. Body mass index > 35
研究者
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