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

Phase 2

Completed

Conditions: Secondary Hyperparathyroidism
Hemodialysis

Interventions: Drug: paricalcitol
Drug: maxacalcitol

Registration Number: NCT00990704

Lead Sponsor: Abbott

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 47

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paricalcitol	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
Maxacalcitol	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

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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)
Mean iPTH at Each Visit	Screening (up to 2 weeks before Baseline) to Week 13
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)
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	Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia	Hypercalcemia was defined as at least 1 corrected calcium \> 11.5 mg/dL or at least 2 consecutive corrected calcium \>= 11.0 mg/dL.
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	Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia	Hypercalcemia was defined as at least 1 corrected calcium \> 11.5 mg/dL or at least 2 consecutive corrected calcium \>= 11.0 mg/dL.
Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline	Over the 12-week treatment period
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

Trial Locations

Locations (14): Site Ref # / Investigator 53789
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Tokyo, Japan
Site Ref # / Investigator 53793
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Toyohashi, Japan
Site Ref # / Investigator 53788
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Yachiyo, Japan
Site Ref # / Investigator 53792
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Matsumoto, Japan
Site Ref # / Investigator 53787
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Chiba, Japan
Site Ref # / Investigator 53786
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Kumagaya, Japan
Site Ref # / Investigator 53796
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Nagasaki, Japan
Site Ref # / Investigator 53790
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Tokyo, Japan
Site Ref # / Investigator 53785
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Tsuchiura, Japan
Site Ref # / Investigator 53794
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Anjo, Japan
Site Ref # / Investigator 53791
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Yokosuka, Japan
Site Ref # / Investigator 53784
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Mito, Japan
Site Ref # / Investigator 21561
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Sapporo, Japan
Site Ref # / Investigator 53795
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Osaka, Japan