| Trial ID: | L0166 |
| Source ID: | NCT05764590
|
| Associated Drug: |
Ap-306
|
| Title: |
A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases|Hyperphosphatemia
|
| Interventions: |
DRUG: AP-306|DRUG: Sevelamer Carbonate
|
| Outcome Measures: |
Primary: To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering, The change in serum phosphorus level from the baseline to the end of treatment, 12 weeks | Other: To evaluate the overall safety of AP-306 assessed by incidence of treatment-emergent adverse events, All adverse events occurred after the study treatment initiation will be collected and their nature, frequency, and severity will be assessed., 15 weeks
|
| Sponsor/Collaborators: |
Sponsor: Alebund Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
55
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-02-20
|
| Completion Date: |
2023-09-14
|
| Results First Posted: |
|
| Last Update Posted: |
2024-01-10
|
| Locations: |
Sichuan Provincial People's Hospital, Chengdu, Sichuan, 610072, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05764590
|
