Secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis
Conditions
Interventions
Product Name: Cinacalcet
Product Code: AMG 073
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Cinacalcet
CAS Number: 364782-34-3
Current Sponsor code: AMG 073
Concentration unit: mg milligram
Sponsors
Amgen Development Europe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalcet when administered during the dialysis study visit.;Secondary Objective: To evaluate the safety of cinacalcet when co-administered with the first major meal after dialysis. To evaluate a predefined strategy to manage nausea/vomiting during the study ;Primary end point(s): The proportion of subjects with a mean iPTH £ 300 pg/mL at weeks 11 and 13 | — |
Countries
Spain
Outcome results
None listed