EUCTR2008-004730-25-IT进行中（未招募）不适用
An open, randomised, controlled, parallel group, Phase III study to investigate the safety and efficacy of fermagate and sevelamer hydrochloride in haemodialysis patients with hyperphosphataemia - ACT 402
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 780
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
- •Subjects will be considered eligible for entry in the study if they meet all of the following criteria. 1. Male or female, aged 18 years 2. Able to comply with the study procedures and medication 3. Written informed consent given 4. On a stable haemodialysis regimen (at least 3x per week) for 12 weeks prior to screening 5. Subject receiving phosphate binder medication(s) at screening, must have been on a stable regimen (dose and medication) for at least 1 month prior to screening and will remain on this regimen until entry into the washout period 6. Subject is not currently receiving any phosphate binding medication at screening (or medication likely to act as a phosphate binder) and has done so for at least one month 7. Willing to abstain from taking any phosphate binder or oral magnesium-, oral aluminium- or oral iron-containing products and preparations other than the study medication 8. If required to take the maximum dose (9000 mg/d) of fermagate, the subject will be willing to have at least three meals per day 9. Has a serum phosphate value of >1.78 mmol/L (>5.5 mg/dL) within the 2 to 4 week washout period or above 3.0 mmol/L (9.3 mg/dL) at any time during washout
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will not be considered eligible for entry in the study if they meet one or more of the following criteria 1. Participation in any clinical trial using an investigational product or device during the 30 days preceding the Screening Visit 2. Previous experience of fermagate treatment 3. A significant history of alcohol, drug or solvent abuse in the opinion of the investigator 4. Any disease or condition, physical or psychological that, in the opinion of the investigator, would compromise the safety of the subject or the likelihood of achieving reliable results or increase the likelihood of the subject being withdrawn 5. Laboratory findings at screening which, in the opinion of the investigator, are clinically significant for this subject population 6. A screen serum magnesium concentration of >2.0 mmol/L (>4.8 mg/dL) 7. A known history of haemochromatosis 8. A serum ferritin level of ≥1000 ng/mL at screen 9. Non-elective hospitalisation in the 4 weeks prior to screening 10. Female subjects who are of childbearing potential and who are neither surgically sterilised nor using reliable contraceptive methods (hormonal, barrier methods or intrauterine device) or who are lactating or pregnant 11. Current hypophosphataemia at screening (last 2 consecutive phosphate values of <0.7 mmol/L [<2.2 mg/dL]) 12. Known history of colorectal malignancy, familial polyposis coli and/or strong family history (in 2 or more first degree relatives) of these terms 13. A QTcB interval of >630 ms at screen 14. Current clinically significant intestinal motility disorder 15. Bowel obstruction with current or previous use of sevelamer HCl 16. Known intolerance to sevelamer HCl or any excipients of fermagate or Renagel medication 17. Subjects with inflammatory bowel disease that, in the investigator?s opinion, is poorly controlled
研究者
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