A phase IV, open-label, multi-centre trial evaluating the conversion from standard phosphate binder therapy to Fosrenol in chronic kidney disease stage 5 patients on haemodialysis

Shire Development Inc0 个研究点目标入组 760 人开始时间: 2007年1月16日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Aged 18 or over and receiving stable regimen of haemodialysis (three times a week) for CKD (stage 5) for at least 2 months prior to screening.
•Females must be non-pregnant and non-lactating.
•On a stable phosphate binder dose (no change in medication or dose for one month) with screening serum phosphorus levels of between 5.6 and 7.5 mg/dL inclusive.
•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

•Subjects with a corrected serum calcium level <2.2mmol/L (8.8mg/dL).
•Subjects with an intact parapthyroid hormone level >500pg/ml or a history of parathyroidectomy within 12 months of screening.
•Any significant GI disorders (including bowel obstruction, active, inflammatory bowel disease, GI motility disorders, abnormal or irregular bowel motion, major GI surgery in last 6 months.
•Subjects receiving aluminium, magnesium, or combination therapy other than sevelamer HCl and calcium as a phosphate binder.

发起方

Shire Development Inc