Clinical trial NCT00701805: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism
Hemodialysis
Keywords: Secondary hyperparathyroidism
Hemodialysis
paricalcitol
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Abbott Japan Co.,Ltd
First posted: 2008-06-19
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: The Percentage of Participants With of Hypercalcemia
timeFrame: Anytime during the study through Week 53
measure: The Percentage of Participants With Hyperphosphatemia
timeFrame: Anytime during the study through Week 53
Secondary outcomes:
measure: The Mean Change in Intact Parathyroid Hormone (iPTH)
timeFrame: From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)
measure: The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit
timeFrame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
measure: The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%
timeFrame: Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)
measure: Change in Mean iPTH
timeFrame: Every week from Baseline through Week 13 and every other week thereafter until Week 53
measure: Duration of 2 Consecutive Decreases in iPTH >= 50%
timeFrame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
measure: Duration of 2 Consecutive iPTH Values <= 180 pg/mL
timeFrame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)
measure: The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit
timeFrame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
measure: The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit
timeFrame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
Other outcomes:
measure: The Percentage of Participants With Hypercalcemia
timeFrame: Anytime from Week 13 through Week 53
Locations:
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
Study officials:
affiliation: Abbott
name: Moriaki KUBO
role: STUDY_DIRECTOR
References: