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Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

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ClinicalTrials.gov Identifier: NCT00701805
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Sponsor:
Collaborator:
Abbott Japan Co.,Ltd
Information provided by:
Abbott

Study Description
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Brief Summary:
The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism Hemodialysis Drug: Paricalcitol Phase 2

Detailed Description:
The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Study Start Date : July 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Paricalcitol 2 µg ± 1 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
 Drug: Paricalcitol
Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.
Other Names:
  • ABT-358
  • Zemplar
Experimental: Paricalcitol 2 µg ± 2 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
 Drug: Paricalcitol
Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.
Other Names:
  • ABT-358
  • Zemplar
Experimental: Paricalcitol 4 µg ± 1 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
 Drug: Paricalcitol
Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.
Other Names:
  • ABT-358
  • Zemplar
Experimental: Paricalcitol 4 µg ± 2 µg
Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.
 Drug: Paricalcitol
Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.
Other Names:
  • ABT-358
  • Zemplar


Outcome Measures
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Primary Outcome Measures :
  1. The Percentage of Participants With of Hypercalcemia [ Time Frame: Anytime during the study through Week 53 ]
    The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study.

  2. The Percentage of Participants With Hyperphosphatemia [ Time Frame: Anytime during the study through Week 53 ]
    The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study.


Secondary Outcome Measures :
  1. The Mean Change in Intact Parathyroid Hormone (iPTH) [ Time Frame: From Baseline to Final Visit (which could occur anytime between study initiation and Week 53) ]
  2. The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit [ Time Frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) ]
  3. The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50% [ Time Frame: Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53) ]
  4. Change in Mean iPTH [ Time Frame: Every week from Baseline through Week 13 and every other week thereafter until Week 53 ]
  5. Duration of 2 Consecutive Decreases in iPTH >= 50% [ Time Frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) ]
  6. Duration of 2 Consecutive iPTH Values <= 180 pg/mL [ Time Frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53) ]
  7. The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit [ Time Frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) ]
  8. The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit [ Time Frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) ]

Other Outcome Measures:
  1. The Percentage of Participants With Hypercalcemia [ Time Frame: Anytime from Week 13 through Week 53 ]
    The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who completed 12 weeks of Study M10-309 (NCT00667576).

Exclusion Criteria:

  • Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone metabolism.
  • Patients with progressive malignancy or clinically significant hepatic disease.
  • Patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
  • Patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701805


Locations
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Japan
Aichi, Japan
Chiba, Japan
Fukuoka, Japan
Hokkaido, Japan
Ibaragi, Japan
Kanagawa, Japan
Kumamoto, Japan
Nagano, Japan
Nagasaki, Japan
Osaka, Japan
Saitama, Japan
Tokyo, Japan
Sponsors and Collaborators
Abbott
Abbott Japan Co.,Ltd
Investigators
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Study Director: Moriaki KUBO Abbott
More Information
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Additional Information:

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Responsible Party: Yoshihiko Ueki, Abbott
ClinicalTrials.gov Identifier: NCT00701805    
Other Study ID Numbers: M10-312
First Posted: June 19, 2008    Key Record Dates
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011
Last Verified: March 2011
Keywords provided by Abbott:
Secondary hyperparathyroidism
Hemodialysis
paricalcitol
Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
 Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases