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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00990704
First received: October 5, 2009
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Secondary Hyperparathyroidism
Hemodialysis
Drug: paricalcitol
Drug: maxacalcitol
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Abbott:

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. [ Time Frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13) ] [ Designated as safety issue: No ]

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 [ Time Frame: During the last 3 weeks (Weeks 11, 12, and 13) ] [ Designated as safety issue: No ]
  • Mean iPTH at Each Visit [ Time Frame: Screening (up to 2 weeks before Baseline) to Week 13 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    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 [ 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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Over the 12-week treatment period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • ABT-358
  • paricalcitol
  • Zemplar
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
Other Name: maxacalcitol

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990704

Locations
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, Japan
Sponsors and Collaborators
Abbott
Investigators
Study Director: Moriaki Kubo Abbott Japan Co.,Ltd
  More Information

No publications provided

Responsible Party: Yoshihiko Ueki, Abbott
ClinicalTrials.gov Identifier: NCT00990704     History of Changes
Other Study ID Numbers: M11-609
Study First Received: October 5, 2009
Results First Received: May 20, 2011
Last Updated: June 30, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
Secondary hyperparathyroidism
Hemodialysis
paricalcitol
maxacalcitol

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Neoplasm Metastasis
Renal Insufficiency, Chronic
Endocrine System Diseases
Neoplasms
Neoplastic Processes
Parathyroid Diseases
Pathologic Processes
Renal Insufficiency
Urologic Diseases
Calcitriol
Ergocalciferols
Maxacalcitol
Anticarcinogenic Agents
Antineoplastic Agents
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Dermatologic Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 23, 2014