| Trial ID: | L1129 |
| Source ID: | NCT03988920
|
| Associated Drug: |
Tenapanor
|
| Title: |
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
|
| Acronym: |
NORMALIZE
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03988920/results
|
| Conditions: |
Hyperphosphatemia|End Stage Renal Disease
|
| Interventions: |
DRUG: Tenapanor|DRUG: Sevelamer Carbonate
|
| Outcome Measures: |
Primary: Achieving Normal Serum Phosphorus Level, Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL, 18 months | Secondary: Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline, The change from the baseline s-P from the parent study until the endpoint visit which was up to 2.5 years after the baseline, up to 2.5 years|Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit, Baseline upon enrollment in the 18-month long-term extension study, up to 18 months
|
| Sponsor/Collaborators: |
Sponsor: Ardelyx
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
172
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-06-15
|
| Completion Date: |
2021-07-31
|
| Results First Posted: |
2023-03-29
|
| Last Update Posted: |
2023-03-29
|
| Locations: |
Ardelyx Site #509, Houston, California, 77099, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03988920
|
