EUCTR2006-003330-15-GB进行中（未招募）1 期
A Phase III, Multicentre, Open Label, Flexible dose, Long term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (incorporating a Comparison with Sevelamer).
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
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
入选标准
- •1. The subject is capable of reading and comprehending the informed consent and complying with study procedures, and provides written informed consent.
- •2. The subject is clinically stable on haemodialysis or peritoneal dialysis for at least 3 months as judged by the Investigator.
- •3. The subject is undergoing regular dialysis treatment:
- •oIf the subject is on haemodialysis, this is scheduled to occur 3 times per week in a hospital or centre setting. The duration must be between 3 to 5 hours, or if high-flux dialysis is being utilised a minimum of 2.5 hours, depending on the standard of care in each centre.
- •oIf the subject is on peritoneal dialysis, this is scheduled to occur either daily APD (Automated Peritoneal Dialysis) or CAPD (Continuous Ambulatory Peritoneal Dialysis), the latter employing at least 3 bag changes per day.
- •4. The subject has calcium dialysate content between 1 to 1.75 mmol/L (2 to 3.5 mEq/L), depending on the standard of care in each centre. Calcium dialysate content should remain constant for the duration of the study.
- •5. The subject is on a stabilised phosphorus diet, as considered appropriate by the physician.
- •6. The subject has Kt/V (single pool) of at least 1.2 for haemodialysis subjects, and a weekly Kt/V value of at least 1.8 for peritoneal dialysis subjects at enrollment.
- •7. The subject, if female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant during the course of the clinical study.
- •8. Male subjects must agree to use appropriate contraception during the course of the clinical study.
- •9. If the Subject was previously in Study E07 and initially received sevelamer, the subject has completed all 12 weeks of study treatment.
- •10. If the Subject was previously in Study E07 and initially received MCI-196 or placebo, the subject has completed all 16 weeks of study treatment.
- •11. If the Subject was previously in Study E08, the subject has completed all 12 weeks of study treatment.
- •12. If the Subject was previously in Study E09, the subject has completed all 12 weeks of study treatment.
- •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
- •1. The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
- •2. The subject has a body mass index (BMI) ?16.0 kg/m2 or >40.0 kg/m2.
- •3. The subject has current or a history of significant gastrointestinal (GI) motility problems, including dysphagia or swallowing difficulty, or GI abnormalities such as chronic or severe constipation, sigmoid colitis, ulcers, or major GI surgery.
- •4. The subject has biliary obstruction or proven liver dysfunction, i.e. cirrhosis, hepatorenal syndrome, or has liver function tests 3 times the normal values for at least 2 of the measurements (ALT, AST, alkaline phosphatase, and gamma-glutamyl-transferase).
- •5. The subject is known to have a positive test for HIV 1 and 2 antibodies.
- •6. The subject has a history of substance or alcohol abuse within the last year.
- •7. The subject has seizure disorders.
- •8. The subject has a history of drug or other allergy that contraindicates their participation.
- •9. The subject is using any of the following drugs:
- •oColesevelam, colestyramine or colestipol
- •10. The subject has a temporary catheter as a vascular access and is showing active signs of inflammation or infection as a result of this.
- •11. The subject has participated in a clinical study with any experimental medication (with the exception of studies MCI-196 E07, E08 or E09) in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent form.
- •12. If on peritoneal dialysis, the subject has a recent history of peritonitis (within the previous 3 months).
研究者
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