Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism

Phase II, Open Study, Exploratory Examination of Efficacy and Safety of Paricalcitol Injection and Maxacalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

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.

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