Phase 4
Completed N=172
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
Hyperphosphatemia · End Stage Renal Disease
Source: ClinicalTrials.gov NCT03988920 ↗
Enrolled (actual)
172
Serious AEs
45.4%
Results posted
Mar 2023
Primary outcomePrimary: Achieving Normal Serum Phosphorus Level — 36; 21 Participants — p=0.7439
◆ Published Evidence
Emerging
18citations · ~9 / year
Tenapanor as Therapy for Hyperphosphatemia in Maintenance Dialysis Patients: Results from the OPTIMIZE Study.
Summary
The study is designed to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus concentration (sP) within the population reference range (sP >2.5 and ≤4.5 mg/dL) in patients with end-stage renal disease (ESRD) on dialysis with hyperphosphatemia (>4.5 mg/dL).
Linked Publications (2)
-
Tenapanor as Therapy for Hyperphosphatemia in Maintenance Dialysis Patients: Results from the OPTIMIZE Study.
-
Tenapanor Improves Long-Term Control of Hyperphosphatemia in Patients Receiving Maintenance Dialysis: the NORMALIZE Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achieving Normal Serum Phosphorus Level |
36; 21 | 0.7439 |
| SECONDARY Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline |
-2.00; -1.91 | — |
| SECONDARY Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit |
-0.47; -0.57 | — |
Eligibility Criteria
Inclusion Criteria
- Must complete TEN-02-301 (PHREEDOM)
Exclusion Criteria
- Schedlued for kidney transplant
- Life expectancy <12 months
Data sourced from ClinicalTrials.gov (NCT03988920) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.