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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00990704
Other study ID # M11-609
Secondary ID
Status Completed
Phase Phase 2
First received October 5, 2009
Last updated June 30, 2011
Start date October 2009
Est. completion date May 2010

Study information

Verified date June 2011
Source Abbott
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
paricalcitol
Intravenous administration 3 times a week immediately before completion of dialysis
maxacalcitol
Intravenous administration 3 times a week immediately before completion of dialysis

Locations

Country Name City State
Japan 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

Sponsors (1)

Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks. Baseline and the last 3 weeks (Weeks 11, 12, and 13) No
Secondary The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks During the last 3 weeks (Weeks 11, 12, and 13) No
Secondary Mean iPTH at Each Visit Screening (up to 2 weeks before Baseline) to Week 13 No
Secondary Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks Baseline and the last 3 weeks (Weeks 11, 12, and 13) No
Secondary Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL. Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia Yes
Secondary Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL. Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia Yes
Secondary Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline Over the 12-week treatment period No
Secondary Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH Over the 12-week treatment period No
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