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

NCT ID: NCT00990704

Last Updated: 2011-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-05-31

Brief 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.

Conditions

Secondary Hyperparathyroidism; Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paricalcitol

2 mcg adjusted by +/- 1 mcg, up to a maximum of 7 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis

Group Type: EXPERIMENTAL

paricalcitol

Intervention Type: DRUG

Intravenous administration 3 times a week immediately before completion of dialysis

Maxacalcitol

5 or 10 mcg adjusted by +/- 2.5 mcg, up to a maximum of 20 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis

Group Type: ACTIVE_COMPARATOR

maxacalcitol

Intervention Type: DRUG

Intravenous administration 3 times a week immediately before completion of dialysis

Interventions

paricalcitol

Intravenous administration 3 times a week immediately before completion of dialysis

Intervention Type: DRUG

maxacalcitol

Intravenous administration 3 times a week immediately before completion of dialysis

Intervention Type: DRUG

Other Intervention Names

ABT-358; Zemplar

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Principal Investigators

Moriaki Kubo

Role: STUDY_DIRECTOR

Abbott Japan Co.,Ltd

Locations

Site Ref # / Investigator 53794

Anjo, , Japan

Site Ref # / Investigator 53787

Chiba, , Japan

Site Ref # / Investigator 53786

Kumagaya, , Japan

Site Ref # / Investigator 53792

Matsumoto, , Japan

Site Ref # / Investigator 53784

Mito, , Japan

Site Ref # / Investigator 53796

Nagasaki, , Japan

Site Ref # / Investigator 53795

Osaka, , Japan

Site Ref # / Investigator 21561

Sapporo, , Japan

Site Ref # / Investigator 53789

Tokyo, , Japan

Site Ref # / Investigator 53790

Tokyo, , Japan

Site Ref # / Investigator 53793

Toyohashi, , Japan

Site Ref # / Investigator 53785

Tsuchiura, , Japan

Site Ref # / Investigator 53788

Yachiyo, , Japan

Site Ref # / Investigator 53791

Yokosuka, , Japan

Countries

Japan

Other Identifiers

M11-609

Identifier Type: -

Identifier Source: org_study_id