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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Calcitriol; Ergocalciferols; Maxacalcitol

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