Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 Chronic Kidney Disease (CKD).


Options:
A: Inclusion Criteria: Chronic Kidney Disease patients not receiving dialysis with: - An iPTH greater than 100 pg/mL \[10.6 pmol/L\] for subjects with stage 3 CKD or greater than or equal to 160 pg/mL \[17.0 pmol/L\] for subjects with stage 4 CKD; - A serum calcium greater than 9.0 mg/dL \[2.25 mmol/L\]; - An estimated GFR less than or equal to 59 mL/min and greater than or equal to 15 mL/min. 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. - Received active vitamin D therapy (i.e., 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 patients prescribed active vitamin D).
B: Inclusion Criteria:

* Inclusion:≥ 18 years of age
* Treated with maintenance hemodialysis - PTH ≥ 300 pg/mL (31.8 pmol/L)
* serum calcium ≥ 8.4mg/dL (2.1 mmol/L)
* Ca x P ≥ 45 mg2\*/dL2 (3.63 mmol2/L2)

Exclusion Criteria: - Exclusion:

* Parathyroidectomy in the 12 weeks before the date of informed consent
* Received therapy with cinacalcet within 3 months of randomization
* Hospitalization within 12 weeks of randomization for any of the following events: a. Myocardial ischemia b. Unstable angina c. Heart Failure (HF) (including any unplanned presentation to a health care facility that would require mechanical intervention \[i.e., unplanned dialysis treatment\]) d. Peripheral vascular disease (other than 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

  * in all instances, the 2 refers to squared.
C: Inclusion Criteria:

* ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
* The mean of 2 iPTH determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/mL (31.8 pmol/L) and less than 800 pg/mL (84.8 pmol/L). If biPTH is determined, the mean levels must be greater than or equal to 150 pg/mL (15.9 pmol/L) and less than 410 pg/mL (43.5 pmol/L)
* The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations must be greater than or equal to 8.4 mg/dL (2.1 mmol/L)

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
* Have had a parathyroidectomy in the 6 months before day 1
* Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If subjects are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days before day 1.
* Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants). The tricyclic antidepressant amitriptyline is permitted. - Experienced a myocardial infarction within 3 months prior to 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 or orally administered medications or an inability to swallow tablets
D: Inclusion Criteria

1. Male or female patients \>= 18 years old.
2. Patient was diagnosed with Stage 5 chronic kidney disease (CKD) and had been receiving intravenous (IV) or oral vitamin D receptor activators (VDRAs) or cinacalcet during the 8 weeks prior to the screening period or naïve patients who had not received VDRA or cinacalcet within 8 weeks of screening.
3. Patient was on maintenance HD (hemodialysis) 3 times weekly (TIW) for at least 3 months prior to screening and was expected to remain on HD for the duration of the study.
4. For entry into the Pre-Treatment Washout Period (for patients who were not naïve to VDRAs and cinacalcet), the patient had to have screening laboratory values of:

   * iPTH level 130 to 700 pg/mL
   * Serum Total Alkaline Phosphatase level \>= 40 U/L
   * Calcium level \<= 10.0 mg/dL (2.49 mmol/L)
   * Calcium-phosphorus product (CaxP) \<= 75 mg2/dL2 (US) and \<= 70 mg2/dL2 (non-US)

Exclusion Criteria

1. Patient had a history of parathyroidectomy.
2. Patient had a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the investigator.
3. Use of known inhibitors (i.e., ketoconazole) or inducers (i.e., carbamazepine) of cytochrome P450 (including grapefruit and/or grapefruit juice) 3A (CYP3A) or drugs metabolized by cytochrome P450 2D6 (CYP2D6) (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants) within 2 weeks prior to study drug administration. Commonly used beta blockers such as metoprolol and carvedilol are allowed but are metabolized by CYP2D6; thus, an adjustment to a lower dose may have been required.
4. Patient was known to be human immunodeficiency (HIV) positive.

Answer: A