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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Paricalcitol

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Secondary hyperparathyroidism, Hemodialysis, paricalcitol

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Paricalcitol 2 µg ± 1 µg

Paricalcitol 2 µg ± 2 µg

Paricalcitol 4 µg ± 1 µg

Paricalcitol 4 µg ± 2 µg

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

The Mean Change in Intact Parathyroid Hormone (iPTH)

The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit

The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%

Change in Mean iPTH

Duration of 2 Consecutive Decreases in iPTH >= 50%

Duration of 2 Consecutive iPTH Values <= 180 pg/mL

The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit

The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit

Full Information

NCT ID

NCT00701805

First Posted

June 17, 2008

Last Updated

March 18, 2011

Sponsor

Abbott

Collaborators

Abbott Japan Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00701805

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

Collaborators

Abbott Japan Co.,Ltd

4. Oversight

Data Monitoring Committee

No

5. Study Description

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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Secondary Hyperparathyroidism, Hemodialysis

Keywords

Secondary hyperparathyroidism, Hemodialysis, paricalcitol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paricalcitol 2 µg ± 1 µg

Arm Type

Experimental

Arm Description

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.

Arm Title

Paricalcitol 2 µg ± 2 µg

Arm Type

Experimental

Arm Description

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.

Arm Title

Paricalcitol 4 µg ± 1 µg

Arm Type

Experimental

Arm Description

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.

Arm Title

Paricalcitol 4 µg ± 2 µg

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Paricalcitol

Other Intervention Name(s)

ABT-358, Zemplar

Intervention Description

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

Primary Outcome Measure Information:

Title

The Percentage of Participants With of Hypercalcemia

Description

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.

Time Frame

Anytime during the study through Week 53

Title

The Percentage of Participants With Hyperphosphatemia

Description

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.

Time Frame

Anytime during the study through Week 53

Secondary Outcome Measure Information:

Title

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)

Title

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)

Title

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)

Title

Change in Mean iPTH

Time Frame

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

Title

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)

Title

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)

Title

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)

Title

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 Pre-specified Outcome Measures:

Title

The Percentage of Participants With Hypercalcemia

Description

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)

Time Frame

Anytime from Week 13 through Week 53

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

No

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moriaki KUBO

Organizational Affiliation

Abbott

Official's Role

Study Director

Facility Information:

City

Aichi

Country

Japan

City

Chiba

Country

Japan

City

Fukuoka

Country

Japan

City

Hokkaido

Country

Japan

City

Ibaragi

Country

Japan

City

Kanagawa

Country

Japan

City

Kumamoto

Country

Japan

City

Nagano

Country

Japan

City

Nagasaki

Country

Japan

City

Osaka

Country

Japan

City

Saitama

Country

Japan

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Links:

URL

http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=12632

Description

prescribing information

Secondary Hyperparathyroidism, Hemodialysis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial