| Trial ID: | L1181 |
| Source ID: | NCT00667576
|
| Associated Drug: |
Maxacalcitol
|
| Title: |
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00667576/results
|
| Conditions: |
Chronic Kidney Disease on Hemodialysis|Secondary Hyperparathyroidism
|
| Interventions: |
DRUG: Maxacalcitol|DRUG: Paricalcitol
|
| Outcome Measures: |
Primary: Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level, Baseline to Week 13 (Final Visit) | Secondary: Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level, Baseline to Week 13 (Final Visit)|Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL), Baseline to Week 13 (Final Visit)|Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level, Through Week 13|Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values, Through Week 13|Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL, Through Week 13 | Other: Percentage of Subjects With Hypercalcemia, Hypercalcemia was defined as at least 1 adjusted calcium value \> 11.5 mg/dL or at least 2 consecutive adjusted calcium values ≥ 11.0 mg/dL, Through Week 13|Percentage of Subjects With Hyperphosphatemia, Hyperphosphatemia was defined as at least 2 consecutive phosphorus values ≥ 7.0 mg/dL, Through Week 13
|
| Sponsor/Collaborators: |
Sponsor: Abbott | Collaborators: Abbott Japan Co.,Ltd
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
153
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-04
|
| Completion Date: |
2009-03
|
| Results First Posted: |
2010-04-02
|
| Last Update Posted: |
2012-01-20
|
| Locations: |
Tokyo, Metropolis, Japan|Aichi, Prefecture, Japan|Chiba, Prefecture, Japan|Fukuoka, Prefecture, Japan|Hokkaido, Prefecture, Japan|Ibaragi, Prefecture, Japan|Kanagawa, Prefecture, Japan|Kumamoto, Prefecture, Japan|Nagano, Prefecture, Japan|Nagasaki, Prefecture, Japan|Osaka, Prefecture, Japan|Saitama, Prefecture, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT00667576
|
