Phase 4
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
Bottom Line
View on ClinicalTrials.gov: NCT03988920 ↗Enrolled (actual)
172
Serious AEs
45.4%
Results posted
Mar 2023
Primary outcome: Primary: Achieving Normal Serum Phosphorus Level — 36; 21 Participants — p=0.7439
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tenapanor (Drug); Sevelamer Carbonate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Ardelyx
- Primary completion
- Jun 2021
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 | — |
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).
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). 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.