Secondary hyperparathyroidism (HPT) in subjects with chronic kidney disease (CKD) receiving maintenance hemodialysis. MedDRA version: 8.1 Level: LLT Classification code 10020708 Term: Hyperparathyroidism secondary
Conditions
Interventions
Product Name: Cinacalcet
Product Code: AMG 073
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cinacalcet
CAS Number: 364782-34-3
Current Sponsor code: AMG 073
Concentration unit: mg mill
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men or women = 18 years of age at screening. Treated with maintenance hemodialysis 3 times a week for = 3 months before randomization. PTH obtained from the central laboratory must be = 300 pg/mL (31.8 pmol/L). Serum calcium obtained from the central laboratory must be = 8.4 mg/dL (2.1 mmol/L). Ca x P obtained from the central laboratory must be = 45 mg2/dL2 (3.63 mmol2/L2). In the investigator’s opinion, the subject is likely to be available during the follow up phase of the study. Agree to be followed for study endpoints until the end of study. Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 13.1). 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: Subjects will be ineligible for the study if they: Have an unstable medical condition in the judgment of the investigator. Parathyroidectomy in the 12 weeks before the date of informed consent. Severe (ie, life-limiting) concomitant disease, including life-threatening malignancy or acquired immune deficiency syndrome (if likely to reduce life expectancy to less than 5 years), or any other life-threatening concomitant disease. Subjects with excised superficial lesions (eg, basal cell and squamous cell carcinoma of the skin) may be included. Received therapy with cinacalcet within 3 months of randomization. Hospitalization within 12 weeks of randomization for any of the following events: a. Myocardial infarction b. Unstable angina c. Heart failure (including any unplanned presentation to a health care facility that would require mechanical intervention [ie, unplanned dialysis treatment]) d. Peripheral vascular disease (other than for dialysis vascular access revision) e. Stroke History of seizure within 12 weeks prior to randomization. Scheduled date for kidney transplant from a known living donor. Anticipated parathyroidectomy within 6 months after randomization. General: - Other investigational procedures are excluded. - Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s). - Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study. - Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. - Subject is pregnant, is breast feeding, or is of child-bearing potential and not using adequate contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of a secondary HPT treatment regimen including cinacalcet compared to a treatment regimen not including cinacalcet (placebo) on the composite of time to all-cause mortality or first non-fatal cardiovascular event (myocardial infarction [MI], hospitalization for unstable angina, heart failure [HF], or peripheral vascular event).;Secondary Objective: To assess the effects of a secondary HPT treatment regimen including cinacalcet versus a treatment regimen not including cinacalcet, by determining: • All-cause mortality • Cardiovascular mortality • Fatal and non-fatal MI • Fatal and non-fatal hospitalization for unstable angina • Fatal and non-fatal HF event • Fatal and non-fatal peripheral vascular event • Fatal and non-fatal stroke • Bone fracture • Parathyroidectomy • The safety and tolerability of cinacalcet.;Primary end point(s): Time to the composite event comprising all-cause mortality or non-fatal cardiovascular events (MI, hospitalization for unstable angina, HF, or peripheral vascular event). | — |
Countries
Austria, Belgium, Denmark, Germany, Hungary, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed