Study to Investigate Cinacalcet Treatment in Haemodialysis Patients with Secondary Hyperparathyroidism - SENSOR

Amgen Development Europe0 个研究点目标入组 800 人开始时间: 2004年11月10日最近更新: 2022年4月19日

试验速览

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•- CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrolment
•- Males or females = 18 years of age at the time of informed consent.
•- Men and women participating in this study must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study. Females must have a negative serum pregnancy test (or definitive evidence to demonstrate lack of pregnancy) within 30 days before randomisation, unless there is a definite history of amenorrhoea.
•- An iPTH determination within 14 days before randomisation must be = 300 pg/mL (biPTH = 150 pg/mL).
•- A serum calcium determination (corrected for calcium) within 14 days before randomisation must be = 8.4 mg/dL [2.1 mmol/L].
•- Signed the Independent Ethics Committee (IEC) approved Informed Consent document, before any study specific procedures are initiated
•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

•- Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator.
•- Are currently breast-feeding.
•- Are performing peritoneal dialysis
•- Have had a parathyroidectomy in the 3 months before day 1.
•- Are currently enrolled in, or have not yet completed at least 30 days before day 1 other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable).
•- Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets.
•- Have a disorder that would interfere with understanding and giving informed consent or compliance with protocol requirements

发起方

Amgen Development Europe