20070360 Incident Dialysis
Condition: Chronic Kidney Disease; Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Cinacalcet; Vitamin D
Intervention description: Cinacalcet is a calcimimetic agent, which is synthesized as a hydrochloride salt.; Titration of active Vitamin D in accordance with treatment practice guidelines in order to treat Secondary Hyperparathyroidism.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Cinacalcet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination
      with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism
      (SHPT) Recently Initiating Hemodialysis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater than or equal to 18 years of age on hemodialysis for > 3 and less than
             or equal to 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 greater than or equal to 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

        Exclusion 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) less than or equal to 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).