Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Condition: Chronic Kidney Disease; Secondary Hyperparathyroidism; Hemodialysis
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Paricalcitol; Cinacalcet
Intervention description: Paricalcitol dosed per label by region (participants were to receive cinacalcet if they developed hypercalcemia); On-label oral cinacalcet by region with low dose vitamin D receptor activator (VDRA) (either doxercalciferol at US sites or alfacalcidol at non-US sites)
Intervention MeSH terms: Cinacalcet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 272.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Zemplar; paricalcitol; IMPACT SHPT; Hemodialysis; Chronic Kidney Disease Stage 5

Summary:

      Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin
      D.
    

Eligibility criteria:

        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.