| Trial ID: | L1741 |
| Source ID: | NCT06206135
|
| Associated Drug: |
The Low-Dose Group (1.5 G/Day) Or The Standard-Dose Group (4 G/Day)
|
| Title: |
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperphosphatemia
|
| Interventions: |
DRUG: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)
|
| Outcome Measures: |
Primary: Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48, Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48, 48 weeks | Secondary: Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL), Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL), 40 ~ 48 weeks|Mean change from baseline to week 48 in serum phosphorus level, Mean change from baseline to week 48 in serum phosphorus level, 48 weeks|Initial dose retention period, Initial dose retention period, Up to 48weeks
|
| Sponsor/Collaborators: |
Sponsor: Kyowa Kirin Korea Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
100
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2023-12-21
|
| Completion Date: |
2025-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-04-29
|
| Locations: |
Jesus Hospital, Jeonju, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT06206135
|
