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

This study has been completed.
Sponsor:
Collaborator:
Abbott Japan Co.,Ltd
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00701805
First received: June 17, 2008
Last updated: March 18, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Secondary Hyperparathyroidism
Hemodialysis
Drug: Paricalcitol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • The Percentage of Participants With of Hypercalcemia [ Time Frame: Anytime during the study through Week 53 ] [ Designated as safety issue: Yes ]
    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.

  • The Percentage of Participants With Hyperphosphatemia [ Time Frame: Anytime during the study through Week 53 ] [ Designated as safety issue: Yes ]
    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:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Change in Mean iPTH [ Time Frame: Every week from Baseline through Week 13 and every other week thereafter until Week 53 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: July 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • paricalcitol
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
  • paricalcitol
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
  • paricalcitol
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
  • paricalcitol

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).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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: NCT00701805

Locations
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
Study Director: Moriaki KUBO Abbott
  More Information

Additional Information:
No publications provided

Responsible Party: Yoshihiko Ueki, Abbott
ClinicalTrials.gov Identifier: NCT00701805     History of Changes
Other Study ID Numbers: M10-312
Study First Received: June 17, 2008
Results First Received: December 28, 2010
Last Updated: March 18, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
Secondary hyperparathyroidism
Hemodialysis
paricalcitol

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014