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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990704
• Other study ID #: M11-609
• 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

Related Conditions & MeSH terms

• Hemodialysis
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

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