| Trial ID: | L0762 |
| Source ID: | NCT04549597
|
| Associated Drug: |
Tenapanor
|
| Title: |
Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia
|
| Acronym: |
OPTIMIZE
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04549597/results
|
| Conditions: |
Chronic Kidney Disease Requiring Chronic Dialysis|Hyperphosphatemia
|
| Interventions: |
DRUG: Tenapanor
|
| Outcome Measures: |
Primary: Effect of Tenapanor to Achieve Target s-P Levels of Less Than or Equal to 5.5 mg/dL, To evaluate the effect of tenapanor alone or in combination with phosphate binders to achieve target serum phosphorus (s-P) levels of ≤5.5 mg/dL when tenapanor is administered as the core therapy for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis., 10 weeks | Secondary: To Evaluate the Effect of Tenapanor to Achieve Various s-P Levels ≤4.5 mg/dL, Evaluating the ability of different treatment regimens to lower s-P to different levels, 10 weeks|To Evaluate the Effect of Tenapanor on Reducing Daily Phosphorus-lowering Therapy Pill Burden., Evaluating the ability of tenapanor to make the phosphate lowering treatment regimen better for patients by evaluating the change in pill weight or pill number from baseline to the end of the 10-week treatment period., 10 weeks
|
| Sponsor/Collaborators: |
Sponsor: Ardelyx
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
333
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-11-20
|
| Completion Date: |
2021-12-01
|
| Results First Posted: |
2023-03-29
|
| Last Update Posted: |
2023-03-29
|
| Locations: |
South Florida Research Institute, Lauderdale Lakes, Florida, 33313, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04549597
|
