Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
Condition: Chronic Kidney Disease on Hemodialysis; Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Maxacalcitol; Paricalcitol
Intervention description: Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 12 weeks.; Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 12 weeks.
Intervention MeSH terms: Maxacalcitol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: chronic kidney disease; secondary hyperparathyroidism; hemodialysis; paricalcitol; maxacalcitol

Summary:

      The purpose of this study was to investigate the initial dose and dose adjustment range for
      paricalcitol injection in patients with chronic kidney disease on hemodialysis who have
      secondary hyperparathyroidism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at
             least 3 months prior to obtaining the informed consent and scheduled to be receiving
             the same hemodialysis during the study period.

          -  Using dialysate with constant concentration of calcium for 4 weeks prior to obtaining
             informed consent and phosphate binder with constant dose regimen for 2 weeks prior to
             obtaining informed consent.

          -  Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL

          -  Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL)

          -  Phosphorus ≤ 6.5 mg/dL

          -  Age ≥ 20 years

        Exclusion Criteria:

          -  History of allergic reaction or significant sensitivity to vitamin D or vitamin D
             related compounds

          -  Parathyroidectomy or ethanol infusion within past year

          -  Progressive malignancy or clinically significant hepatic diseases, severe
             cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes
             mellitus

          -  Drug or alcohol abuse within past 6 months

          -  Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet,
             bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds
             (other than study drug), or other drugs that may affect calcium or bone metabolism
             (other than estrogen or progestin, vitamin K2)

          -  Will need to take chronic dose (≥ 2 consecutive weeks) of cytochrome P450 (CYP3A)
             inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g.,
             carbamazepine, rifampicin)

          -  Taking aluminum containing products (2 weeks prior to consent)