| Trial ID: | L1576 |
| Source ID: | NCT00701805
|
| Associated Drug: |
Paricalcitol
|
| Title: |
Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00701805/results
|
| Conditions: |
Secondary Hyperparathyroidism|Hemodialysis
|
| Interventions: |
DRUG: Paricalcitol
|
| Outcome Measures: |
Primary: 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: 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)|Duration of 2 Consecutive iPTH Values <= 180 pg/mL, 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, 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, From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53) | Other: The Percentage of Participants With 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 Study M10-312 (Weeks 13 through 53), Anytime from Week 13 through Week 53
|
| Sponsor/Collaborators: |
Sponsor: Abbott | Collaborators: Abbott Japan Co.,Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
107
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-07
|
| Completion Date: |
2009-12
|
| Results First Posted: |
2011-04-19
|
| Last Update Posted: |
2011-04-19
|
| Locations: |
Aichi, Japan|Chiba, Japan|Fukuoka, Japan|Hokkaido, Japan|Ibaragi, Japan|Kanagawa, Japan|Kumamoto, Japan|Nagano, Japan|Nagasaki, Japan|Osaka, Japan|Saitama, Japan|Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00701805
|
