Treatment of secondary hyperparathyroidism (SHPT) _______________________________________________ Tratamiento del hiperparatiroidismo secundario (HPTS) MedDRA version: 9.1 Level: LLT Classification code 10020708 Term: Hyperparathyroidism secondary
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will be eligible for the study if they meet all of the following criteria: Adults ≥ 18 years of age on hemodialysis for > 3 and ≤ 12 months prior to enrollment into the study Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 300 pg/mL (31.8 pmol/L); or biPTH > 160 pg/mL (17.0 pmol/L) Mean of 2 corrected serum calcium determinations drawn on the same day as the PTH determinations ? 8.4 mg/dL (2.1 mmol/L) Subject will be able to complete the study, to the best of his/her knowledge Before any study-specific procedure, the appropriate written informed consent must be obtained 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 fulfill any of the following criteria: Mean of 2 PTH determinations during the screening period (drawn at least 2 days apart) > 800 pg/mL (84.9 pmol/L); or biPTH > 430 pg/mL (45.6 pmol/L) AND receiving vitamin D on entering screening Parathyroidectomy (partial or full) ≤ 6 months before entering screening Anticipated parathyroidectomy (partial or full) within 6 months after randomization Have a scheduled date for kidney transplant surgery Received cinacalcet since initiating hemodialysis Have received vitamin D therapy for less than 30 days before entering screening or required a change in prescribed vitamin D brand or dose within 30 days before entering screening. If subjects are not receiving vitamin D therapy, they must remain free of vitamin D therapy for the 30 days before entering screening Subject is pregnant (eg, positive HCG test) or is breast-feeding Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the study (screening and post enrollment) Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets Known sensitivity, intolerance, or other adverse response to cinacalcet which would prevent on-study treatment compliance Have an unstable medical condition within 30 days before screening, or otherwise unstable in the judgment of the investigator Subject is currently enrolled in, or fewer than 30 days prior to entering screening have passed since subject received other investigational agent(s) (devices or drug).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the ability of a treatment strategy that includes the use of cinacalcet in combination with low dose active vitamin D sterols (if prescribed) to control parathyroid hormone (PTH) compared with flexible active vitamin D sterols (flexible vitamin D) dosing (if prescribed) per standard treatment guidelines over a 6-month period in subjects recently initiating hemodialysis (within 3 to 12 months of enrollment) with SHPT and CKD;Secondary Objective: To evaluate the effect of the treatment strategy on achieving and maintaining treatment targets for PTH, calcium (Ca), and phosphorus (P) To determine the safety and tolerability of cinacalcet in a population of subjects recently initiating dialysis;Primary end point(s): Achievement of a ≥ 30% reduction in mean PTH from baseline to during the efficacy assessment phase at month 6 (weeks 22 to 26) | — |
Countries
Belgium, France, Germany, Greece, Hungary, Ireland, Italy, Norway, Spain, United Kingdom
Outcome results
None listed