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

March 18, 2011 updated by: Abbott

Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

107

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
      • Aichi, Japan
      • Chiba, Japan
      • Fukuoka, Japan
      • Hokkaido, Japan
      • Ibaragi, Japan
      • Kanagawa, Japan
      • Kumamoto, Japan
      • Nagano, Japan
      • Nagasaki, Japan
      • Osaka, Japan
      • Saitama, Japan
      • Tokyo, Japan

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:

  • 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).

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Zemplar
  • ABT-358
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:
  • Zemplar
  • ABT-358
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:
  • Zemplar
  • ABT-358
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:
  • Zemplar
  • ABT-358

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Anytime during the study through Week 53
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.
Anytime during the study through Week 53

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)
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)
From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
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)
Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)
Change in Mean iPTH
Time Frame: Every week from Baseline through Week 13 and every other week thereafter until Week 53
Every week from Baseline through Week 13 and every other week thereafter until Week 53
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)
From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
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)
From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)
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)
From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
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)
From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Anytime from Week 13 through Week 53

Collaborators and Investigators

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

Sponsor

Abbott

Collaborators

Abbott Japan Co.,Ltd

Investigators

  • Study Director: Moriaki KUBO, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

July 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

April 19, 2011

Last Update Submitted That Met QC Criteria

March 18, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-312

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.

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