EUCTR2016-004789-24-AT进行中（未招募）1 期
The Effect of Phosphate Lowering using sucroferric oxyhydroxide (PA21) on Calcification Propensity of Serum– a randomized, controlled, open-label, cross-over trial - PA21-T50-CKD5D
Ordensklinikum Linz, Krankenhaus der Elisabethinen Linz GmbH, III. Interne0 个研究点开始时间: 2017年1月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Adults = 18 years old
- •Prevalent patients (= 3 months on dialysis) treated with thrice weekly hemodialysis (HD) or hemodiafiltration (HDF)
- •Hyperphosphatemia (serum phosphate > upper limit of normal within the last 3 months) or current phosphate binder use
- •No use or constant dose of vitamin D and/or calcimimetics for =2 weeks
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Allergy to sucroferric oxyhydroxide (PA21), to other ingredients of Velphoro or to any iron-medication
- •Current or history of calciphylaxis (calcific uremic arteriolopathy – CUA)
- •PTH >800 pg/ml
- •Parathyreoidectomy planned or expected
- •Significant GI or hepatic disorders
- •Hypercalcemia (total sCa >2.6 mmol/l) at screening
- •Antacids containing aluminum, calcium, magnesium or bicarbonate
- •Oral iron treatments/supplements
- •Pregnant and nursing (lactating) women
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