NCT00701805

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 19, 2011

Completed
Last Updated

April 19, 2011

Status Verified

March 1, 2011

Enrollment Period

1.4 years

First QC Date

June 17, 2008

Results QC Date

December 28, 2010

Last Update Submit

March 18, 2011

Conditions

Secondary HyperparathyroidismHemodialysis

Keywords

Secondary hyperparathyroidismHemodialysisparicalcitol

Outcome Measures

Primary Outcomes (2)

  • The Percentage of Participants With of Hypercalcemia

    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

    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 Outcomes (8)

  • The Mean Change in Intact Parathyroid Hormone (iPTH)

    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

    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%

    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

    Every week from Baseline through Week 13 and every other week thereafter until Week 53

  • Duration of 2 Consecutive Decreases in iPTH >= 50%

    From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

  • +3 more secondary outcomes

Other Outcomes (1)

  • The Percentage of Participants With Hypercalcemia

    Anytime from Week 13 through Week 53

Study Arms (4)

Paricalcitol 2 µg ± 1 µg

EXPERIMENTAL

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

Paricalcitol 2 µg ± 2 µg

EXPERIMENTAL

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

Paricalcitol 4 µg ± 1 µg

EXPERIMENTAL

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

Paricalcitol 4 µg ± 2 µg

EXPERIMENTAL

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

Interventions

ParicalcitolDRUG

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

Also known as: ABT-358, Zemplar
Paricalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Aichi, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Ibaraki, Japan

Location

Unknown Facility

Kanagawa, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Nagano, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Saitama, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Limitations and Caveats

The dose titration scheme was revised because of the incidence of hypercalcemia in the early weeks of the study.

Results Point of Contact

Title
Global Medical Services
Organization
Abbott
800-633-9110

Study Officials

  • Moriaki KUBO

    Abbott

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 19, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 19, 2011

Results First Posted

April 19, 2011

Record last verified: 2011-03

Locations

JP(12)