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

June 30, 2011 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: paricalcitol
Intravenous administration 3 times a week immediately before completion of dialysis
Other Names:
  • Zemplar
  • ABT-358
Active Comparator: 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
Drug: maxacalcitol
Intravenous administration 3 times a week immediately before completion of dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline and the last 3 weeks (Weeks 11, 12, and 13)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During the last 3 weeks (Weeks 11, 12, and 13)
Mean iPTH at Each Visit
Time Frame: Screening (up to 2 weeks before Baseline) to Week 13
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
Time Frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13)
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
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
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
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
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
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
Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline
Time Frame: Over the 12-week treatment period
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
Time Frame: Over the 12-week treatment period
Over the 12-week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Moriaki Kubo, Abbott Japan Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 5, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (Estimate)

October 7, 2009

Study Record Updates

Last Update Posted (Estimate)

July 11, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M11-609

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe