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Completed

NCT Number: NCT00701805

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

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).

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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hemodialysis Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aichi, Japan

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Paricalcitol

Drug

Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.

Other names: ABT-358, Zemplar

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • Abbott Japan Co.,Ltd

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 19, 2008
Registry last updated
Apr 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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