Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
Condition: Secondary Hyperparathyroidism; Hemodialysis
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: paricalcitol; maxacalcitol
Intervention description: Intravenous administration 3 times a week immediately before completion of dialysis; Intravenous administration 3 times a week immediately before completion of dialysis
Intervention MeSH terms: Maxacalcitol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Secondary hyperparathyroidism; Hemodialysis; paricalcitol; maxacalcitol

Summary:

      This study is a exploratory comparison of the efficacy and safety of paricalcitol injection
      with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis
      with secondary hyperparathyroidism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic kidney disease (CKD) patients with iPTH >=300 pg/mL, adjusted calcium >=8.4 to
             <10.2 mg/dL, and phosphorus <=6.5 mg/dL

          -  Patients receiving dialysis 3 times weekly for at least 3 months before informed
             consent was obtained and scheduled to receive the same hemodialysis during the study
             period

          -  Patients using dialysate with constant concentration of calcium for 4 weeks before
             informed consent was obtained and receiving phosphate binder with constant dose
             regimen for 2 weeks before informed consent was obtained

        Exclusion Criteria:

          -  Patients taking drugs that affect iPTH, calcium, or bone metabolism

          -  Patients with a history of allergic reaction or significant sensitivity to vitamin D

          -  Patients who received parathyroidectomy or ethanol infusion within 1 year before
             informed consent was obtained

          -  Patients with malignancy or with clinically significant hepatic disease (liver
             function tests more than 3 times the upper limit of normal) or with refractory hepatic
             disease

          -  Patients with cardiovascular disease designated as New York Heart Association Class
             III or IV or with any of the following cardiovascular or cerebrovascular diseases
             within 6 months before informed consent was obtained:

               -  Acute coronary syndrome (myocardial infarction or unstable angina) or acute
                  cerebral vascular disease (cerebral infarction or cerebral hemorrhage)

               -  Coronary arterial revascularization (such as coronary artery bypass grafting,
                  percutaneous transluminal coronary angioplasty)

               -  Cerebral arterial revascularization (such as cerebral aneurysm clipping, cerebral
                  aneurysm embolization, carotid artery endarterectomy)

               -  Arteriosclerosis obliterans with rest pain (Fontaine classification III or more
                  severe)

          -  Patients with severe hypertension (defined as mean resting blood pressure taken with
             the patient in a supine position before dialysis and at 6 dialyses sessions before
             informed consent was obtained: systolic >= 180 mmHg and diastolic >= 110 mmHg)

          -  Patients with uncontrolled diabetes mellitus (defined as mean glycosylated hemoglobin
             >=8% for 3 months before informed consent was obtained)

          -  Patients with a history of drug or alcohol abuse within 6 months before informed
             consent was obtained

          -  Patients who require chronic use of cytochrome P450 (CYP3A) inhibitors or inducers

          -  Patients who are taking products that contain aluminum 2 weeks before informed consent
             was obtained

          -  Patients who have taken paricalcitol in the past