| Trial ID: | L1396 |
| Source ID: | NCT01115543
|
| Associated Drug: |
Alfacalcidol And Calcitriol
|
| Title: |
Efficacy and Safety of Alfacalcidol Compared to Calcitriol for Treatment of Secondary Hyperparathyroidism
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Secondary Hyperparathyroidism|End Stage Renal Disease
|
| Interventions: |
DRUG: alfacalcidol and calcitriol
|
| Outcome Measures: |
Primary: Reduction of intact parathyroid hormone levels, 48 weeks | Secondary: hypercalcemia and hyperphosphatemia, proportion of the patients who achieved a target PTH, changes in plasma calcium and phosphorus, the proportion of the patients who had hypercalcemia (plasma corrected calcium \> 10.8 mg/dl), hyperphosphatemia (plasma phosphorus \> 6.0 mg/dl) and calcium-phosphorus products \> 55 mg2/dl2 between groups., 48 weeks
|
| Sponsor/Collaborators: |
Sponsor: Mahidol University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-08
|
| Completion Date: |
2009-08
|
| Results First Posted: |
|
| Last Update Posted: |
2010-05-04
|
| Locations: |
Siriraj Medical School, Bangkok-noi, Bangkok, 10700, Thailand
|
| URL: |
https://clinicaltrials.gov/show/NCT01115543
|