Secondary Hyperparathyroidism in Chronic Kidney Disease subjects not receiving dialysis
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males or females = 18 years of age at the start of screening. Agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study (all females must have a negative serum pregnancy test within 30 days before day 1). One iPTH determination obtained from the central laboratory = 100 pg/mL [10.6 pmol/L] for stage 3 CKD or = 160pg/mL [17.0pmol/L] for stage 4 CKD. One serum calcium determination obtained from the central laboratory = 9.0mg/dL [2.25mmol/L]. CKD subjects not receiving dialysis with an estimated GFR = 59mL/min and = 15mL/min. 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: Have an unstable medical condition, defined as having been hospitalized within 30 days before day 1, or otherwise unstable in the judgment of the investigator. Experienced a myocardial infarction (MI) within 3 months before day 1. Likely to initiate dialysis (in the opinion of the investigator) or are scheduled to undergo renal transplantation within 28 weeks after day 1. Laboratory evidence of primary HPT. Received active vitamin D therapy (ie, 1-hydroxylated metabolites of vitamin D) for less than 30 days before day 1 or required a change in active vitamin D brand or dose level within 30 days before day 1 (for subjects prescribed active vitamin D). Received, within 30 days before day 1, therapy with cinacalcet. General: - Other investigational products or procedures. - 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). - Pregnant or nursing - Received a kidney transplant - Known sensitivity to any of the products to be administered during dosing. - Gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or has an inability to swallow tablets - Previous participation in a study with cinacalcet. - Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of cinacalcet compared with placebo by determining the proportion of subjects achieving a mean reduction of = 30% in intact parathyroid hormone (iPTH) during the efficacy assessment phase. ;Secondary Objective: To evaluate the efficacy of cinacalcet compared with placebo during the efficacy assessment phase by determining: - The proportion of subjects achieving a target iPTH during the efficacy assessment phase, defined as: a mean iPTH = 70pg/mL for subjects with stage 3 chronic kidney disease (CKD), or a mean iPTH = 110pg/mL for subjects with stage 4 CKD - The mean percent change from baseline in iPTH To assess the safety and tolerability of cinacalcet compared with placebo in CKD subjects not receiving dialysis by determining: - The nature, frequency, severity, and relationship to treatment of all adverse events - Changes in laboratory parameters, including clinical chemistry, hematology, and urine electrolyte excretion (calcium and phosphorus) using 24-hour urine collections. ;Primary end point(s): The primary endpoint is the proportion of subjects with a mean reduction of = 30% in iPTH during the efficacy assessment phase. For each subject, baseline iPTH is defined as the average of the 2 iPTH values collected during the screening phase and pre-dose on day 1. A responder is defined as a subject whose mean percent reduction from baseline in iPTH during the efficacy assessment phase is = 30%. The mean percent change in iPTH during the efficacy assessment phase is defined as the average percent change of all the available iPTH values at weeks 20, 24, 28, and 32 of the study. For subjects with no data during weeks 20, 24, 28, and 32, the last available post-baseline iPTH value will be used to calculate the endpoint. | — |
Countries
Italy, Norway, Spain, Sweden
Outcome results
None listed