A Phase 4 interventional study of Tenapanor and Sevelamer Carbonate in Hyperphosphatemia and End Stage Renal Disease, sponsored by Ardelyx. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Ardelyx · Phase 4, Interventional, and Treatment
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).
Patients who complete the TEN-02-301 study (PHREEDOM) may be eligible to enroll into TEN-02-401 (NORMALIZE).
Patients from the TEN-02-301 tenapanor arm will either receive only tenapanor or be given sevelamer in addition to tenapanor based on their sP. Patients from the TEN-02-301 sevelamer arm will be given tenapanor in addition to their sevelamer dose and the sevelamer dose will then be adjusted based on their sP following a protocol-specified dose titration schedule. Patients will be monitored for safety and efficacy with in-office and telephone visits for up to an additional 18 months.
Laboratory assessments will be measured at every visit (Weeks 1, 2, 3, 4, 6 and 8 and Months 3, 6, 9, 12, 15 and 18) using a central laboratory.
Safety assessments will be performed during the study and will include physical examinations, vital signs (blood pressure and pulse), body weights, clinical laboratory evaluations, 12-lead electrocardiograms (ECGs), and adverse event (AE) monitoring.
173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.
This study's enrollment of 172 is above the median of 101 across 143 interventional studies indexed under Hyperphosphatemia.
Browse Hyperphosphatemia studies →Ardelyx is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Drug: Tenapanor · Drug: Sevelamer Carbonate
Sevelamer will be administered QD, BID or TID and tenapanor will be added to achieve desired serum phosphorus level and sevelamer dose will be decreased as needed
Drug: Tenapanor · Drug: Sevelamer Carbonate
NHE3 Inhibitor
Phosphate binder
Achieving Normal Serum Phosphorus Level
Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL
Time frame: 18 months
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
Time frame: 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
Time frame: up to 18 months
| Milestone | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor |
|---|---|---|
| Started | 111 | 61 |
| Completed | 89 | 35 |
| Not completed | 22 | 26 |
Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL
| Participants | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor |
|---|---|---|
| Achieving Normal Serum Phosphorus Level | 36 | 21 |
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
| mg/dL | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor |
|---|---|---|
| Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline | -2.00 ± 2.248 | -1.91 ± 1.982 |
Baseline upon enrollment in the 18-month long-term extension study
| mg/dL | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor |
|---|---|---|
| Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit | -0.47 ± 2.084 | -0.57 ± 2.422 |
Collected over 1 year, 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tenapanor w/Sevelamer | 5/111 (4.5%) | 56/111 (50.5%) | 91/111 (82%) |
| Sevelamer w/Tenapanor | 4/61 (6.6%) | 22/61 (36.1%) | 52/61 (85.2%) |
| Event | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor |
|---|---|---|
| COVID-19Infections and infestations | 6/111 | 1/61 |
| CelulitisInfections and infestations | 2/111 | 3/61 |
| AnaemiaBlood and lymphatic system disorders | 0/111 | 3/61 |
| COVD-19 pnuemoniaInfections and infestations | 4/111 | 1/61 |
| SepsisInfections and infestations | 3/111 | 2/61 |
| Acute Myocardial InfarctionCardiac disorders | 3/111 | 2/61 |
| Cardiac Failure CongestiveCardiac disorders | 2/111 | 2/61 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 2/111 | 2/61 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/111 | 2/61 |
| PneumoniaInfections and infestations | 3/111 | 1/61 |
| Event | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 11/111 | 27/61 |
| FallInjury, poisoning and procedural complications | 9/111 | 6/61 |
| HyperkalemiaMetabolism and nutrition disorders | 8/111 | 6/61 |
| VomitingGastrointestinal disorders | 5/111 | 5/61 |
| NasopharyngitisInfections and infestations | 9/111 | 1/61 |
| COVID-19Infections and infestations | 8/111 | 4/61 |
| NauseaGastrointestinal disorders | 8/111 | 2/61 |
| HypotensionVascular disorders | 8/111 | 3/61 |
| PneumoniaInfections and infestations | 5/111 | 4/61 |
| ConstipationGastrointestinal disorders | 3/111 | 4/61 |
| Age, Continuous(years) | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor | Total |
|---|---|---|---|
| Mean | 55.97 ± 12.146 | 58.48 ± 14.028 | 56.85 ± 12.861 |
| Sex: Female, Male(Participants) | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor | Total |
|---|---|---|---|
| Female | 46 | 17 | 63 |
| Male | 65 | 44 | 109 |
| Ethnicity (NIH/OMB)(Participants) | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor | Total |
|---|---|---|---|
| Hispanic or Latino | 31 | 20 | 51 |
| Not Hispanic or Latino | 80 | 41 | 121 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor | Total |
|---|---|---|---|
| American Indian or Alaska Native | 7 | 0 | 7 |
| Asian | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 59 | 27 | 86 |
| White | 44 | 31 | 75 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor | Total |
|---|---|---|---|
| United States | 111 | 61 | 172 |
| Region of Enrollment(participants) | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor | Total |
|---|---|---|---|
| United States | 111 | 61 | 172 |
| BMI(kg/m^2) | Tenapanor w/Sevelamer | Sevelamer w/Tenapanor | Total |
|---|---|---|---|
| Mean | 31.90 ± 7.360 | 29.33 ± 7.472 | 30.98 ± 7.480 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Tenapanor