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

Primary Purpose

Secondary Hyperparathyroidism, Hemodialysis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
paricalcitol
maxacalcitol
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Secondary hyperparathyroidism, Hemodialysis, paricalcitol, maxacalcitol

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Ref # / Investigator 53794
  • Site Ref # / Investigator 53787
  • Site Ref # / Investigator 53786
  • Site Ref # / Investigator 53792
  • Site Ref # / Investigator 53784
  • Site Ref # / Investigator 53796
  • Site Ref # / Investigator 53795
  • Site Ref # / Investigator 21561
  • Site Ref # / Investigator 53789
  • Site Ref # / Investigator 53790
  • Site Ref # / Investigator 53793
  • Site Ref # / Investigator 53785
  • Site Ref # / Investigator 53788
  • Site Ref # / Investigator 53791

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paricalcitol

Maxacalcitol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Mean iPTH at Each Visit
Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks
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.
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.
Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline
Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH

Full Information

First Posted
October 5, 2009
Last Updated
June 30, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00990704
Brief Title
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Hemodialysis
Keywords
Secondary hyperparathyroidism, Hemodialysis, paricalcitol, maxacalcitol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol
Arm Type
Experimental
Arm Description
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
Arm Title
Maxacalcitol
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
paricalcitol
Other Intervention Name(s)
ABT-358, Zemplar
Intervention Description
Intravenous administration 3 times a week immediately before completion of dialysis
Intervention Type
Drug
Intervention Name(s)
maxacalcitol
Intervention Description
Intravenous administration 3 times a week immediately before completion of dialysis
Primary Outcome Measure Information:
Title
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.
Time Frame
Baseline and the last 3 weeks (Weeks 11, 12, and 13)
Secondary Outcome Measure Information:
Title
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
Time Frame
During the last 3 weeks (Weeks 11, 12, and 13)
Title
Mean iPTH at Each Visit
Time Frame
Screening (up to 2 weeks before Baseline) to Week 13
Title
Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks
Time Frame
Baseline and the last 3 weeks (Weeks 11, 12, and 13)
Title
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
Description
Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.
Time Frame
Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia
Title
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
Description
Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL.
Time Frame
Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia
Title
Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline
Time Frame
Over the 12-week treatment period
Title
Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH
Time Frame
Over the 12-week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moriaki Kubo
Organizational Affiliation
Abbott Japan Co.,Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Site Ref # / Investigator 53794
City
Anjo
Country
Japan
Facility Name
Site Ref # / Investigator 53787
City
Chiba
Country
Japan
Facility Name
Site Ref # / Investigator 53786
City
Kumagaya
Country
Japan
Facility Name
Site Ref # / Investigator 53792
City
Matsumoto
Country
Japan
Facility Name
Site Ref # / Investigator 53784
City
Mito
Country
Japan
Facility Name
Site Ref # / Investigator 53796
City
Nagasaki
Country
Japan
Facility Name
Site Ref # / Investigator 53795
City
Osaka
Country
Japan
Facility Name
Site Ref # / Investigator 21561
City
Sapporo
Country
Japan
Facility Name
Site Ref # / Investigator 53789
City
Tokyo
Country
Japan
Facility Name
Site Ref # / Investigator 53790
City
Tokyo
Country
Japan
Facility Name
Site Ref # / Investigator 53793
City
Toyohashi
Country
Japan
Facility Name
Site Ref # / Investigator 53785
City
Tsuchiura
Country
Japan
Facility Name
Site Ref # / Investigator 53788
City
Yachiyo
Country
Japan
Facility Name
Site Ref # / Investigator 53791
City
Yokosuka
Country
Japan

12. IPD Sharing Statement

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

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