| Trial ID: | L1059 |
| Source ID: | NCT06712654
|
| Associated Drug: |
Ap306 75mg Tid
|
| Title: |
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 At Fixed Doses in Patients with Hyperphosphatemia
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperphosphatemia|Chronic Kidney Disease Requiring Hemodialysis
|
| Interventions: |
DRUG: AP306 75mg TID|DRUG: AP306 100mg TID|DRUG: AP306 125mg TID|DRUG: AP306 125mg BID|DRUG: AP306 150mg BID|DRUG: Placebo TID
|
| Outcome Measures: |
Primary: To evaluate the efficacy of AP306 assessed by serum phosphate lowering, The change in serum phosphate from the baseline to the end of treatment or before the initiation of rescue therapy, 12 weeks | Other: To evaluate the overall safety of AP306 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: |
144
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2025-04-10
|
| Completion Date: |
2025-12-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-02
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT06712654
|
