Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis
Condition: Hyperparathyroidism, Secondary
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Traditional Vitamin D Therapy; Cinacalcet
Intervention description: Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT) in this study will be administered according to strategies that have been used in clinical practice and that conform to current therapeutic recommendations and available clinical practice guidelines and product labeling.; Subjects randomized to treatment with cinacalcet will receive an initial oral dose of 30 mg once daily. Doses will be titrated incrementally to 60, 90,120, and 180 mg per day based upon periodic measurements of serum calcium and plasma PTH levels. Cinacalcet is formulated as light green tablets in 30, 60, and 90 mg free-based equivalents. Tablets will be 30, 60, and 90 mg, graduated in size, smallest to largest. Combinations of these 3 fixed dosage formulations will be used to achieve the 120 and 180 mg daily doses.
Intervention MeSH terms: Vitamin D; Cinacalcet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 312.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Secondary Hyperthyroidism; Hemodialysis; Parathyroid; PARADIGM

Summary:

      The purpose of this study is to determine the efficacy of treatment with cinacalcet to manage
      plasma parathyroid levels as to compared traditional vitamin D therapy, whether given orally
      or intravenously, among hemodialysis subjects with secondary hyperparathyroidism when the
      doses are adjusted appropriately to maintain serum calcium and phosphorous levels with
      currently recommended ranges.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years at screening

          -  Treated with maintenance hemodialysis 3 times a week for ≥ 3 months prior to screening

          -  Informed consent provided by the study candidate

          -  For subjects NOT receiving cinacalcet and/or vitamin D therapy for SHPT within 60 days
             prior to enrollment: Plasma PTH levels ≥ 450 pg/mL (50 pmol/L) during screening, as
             obtained from the central laboratory and, Serum corrected total calcium ≥ 8.4 mg/dL
             (2.1 mmol/L) and < 10.2 mg/dL (2.55 mmol/L) during screening, as obtained from the
             central laboratory

        Exclusion Criteria:

          -  Parathyroidectomy in the 12 weeks before the date of informed consent

          -  History of seizure within 12 weeks prior to randomization

          -  Scheduled for kidney transplant

          -  Parathyroidectomy anticipated within the next 6 months

          -  Liver function tests > than 2 x the Upper Limit of Normal

          -  Prior use of bisphosphonates, or expected to receive bisphosphonates during the trial

          -  Subject has previously enrolled in this study

          -  General

          -  Other investigational procedures are excluded

          -  Currently enrolled in another investigational device or drug study, or less than 30
             days since ending another investigational device or drug study(s), or receiving other
             investigational agent(s)

          -  Subject (male or female) is not willing to use highly effective contraception during
             treatment and for at least one month (women) and 3 months (men) after the end of
             treatment

          -  Subject is pregnant or breast feeding, or planning to become pregnant during study or
             within 1 month after the end of treatment Male subject with a pregnant partner who is
             not willing to use a condom during treatment and for at least 1 month after the end of
             treatment

          -  Subject has known sensitivity or intolerance to any of the protocol required therapies

          -  Subject will not be available for protocol-required study visits, to the best of the
             subject and investigator's knowledge

          -  Subject has any kind of disorder that, in the opinion of the investigator, may
             compromise the ability of the subject to give written informed consent and/or to
             comply with all required study procedures