A Phase 3 interventional study of Tenapanor and Placebo in Hyperphosphatemia, sponsored by Ardelyx. Completed at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by Ardelyx · Phase 3, Interventional, and Treatment
This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized withdrawal period followed by an open label long term safety extension will evaluate the safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD) on hemodialysis and peritoneal dialysis.
The study consists of a screening visit, a phosphate binder-free washout period of up to 4 weeks, a 26-week treatment period, an up to 12-week placebo-controlled, randomized withdrawal period, during which patients are randomized 1:1 to either remain on their tenapanor treatment or placebo, followed by an open label safety extension period for a total treatment period of up to 52 weeks. An active control group, for safety analysis only, will receive sevelamer carbonate, open label, for the entire 52-week study period
Depending on increase in serum phosphate (s-P) levels, subjects can be randomized 2 or 3 weeks after being taken off their phosphate lowering medication.
Subjects who qualify to enroll in the study will be randomized 3:1 to either receive tenapanor at a dose of 30 mg bid or sevelamer carbonate.
173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.
This study's enrollment of 1,559 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
During the 26-week open label part, all enrolled subjects will receive 30 mg BID doses of tenapanor. Investigators may decrease or increase the dose in 10 mg increments to a minimum of 10 g BIDor a maximum of 30 mg BID
Drug: Tenapanor
Placebo
Drug: Placebo
Subjects randomized into the active control group, for safety analysis, will receive sevelamer carbonate, open label, for the entire 52-week study period. Sevelamer carbonate will be dosed based on package insert instructions (standard of care)
Drug: Sevelamer Carbonate
Active Drug
Also known as: RDX5791, AZD1722
Inactive Drug
Active control
Also known as: Renvela
Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the Responder Population
Patients with at least a 1.2 mg/dL decrease in serum phosphorus during the first 26 weeks of the study were defined as the responder population.
Time frame: 12 weeks (randomized withdrawal period)
Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the ITT Population
Placebo Adjusted Change in Serum Phosphorus from the beginning to the end of the Randomized Withdrawal Period in all patients
Time frame: 12 weeks (randomized withdrawal period)
Serum Phosphorus From Baseline
Serum Phosphorus from baseline (post washout) to end of 26 week period
Time frame: 26 weeks (open label treatment period)
| Milestone | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate |
|---|---|---|---|
| Started | 0 | 1559 | 0 |
| Completed | 0 | 564 | 0 |
| Not completed | 0 | 995 | 0 |
| Withdrew: Screen failure (did not meet study entry requirements) | 0 | 995 | 0 |
| Milestone | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate |
|---|---|---|---|
| Started | 423 | 0 | 141 |
| Completed | 256 | 0 | 117 |
| Not completed | 167 | 0 | 24 |
| Milestone | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate |
|---|---|---|---|
| Started | 129 | 127 | 117 |
| Completed | 99 | 99 | 112 |
| Not completed | 30 | 28 | 5 |
| Milestone | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate |
|---|---|---|---|
| Started | 222 | 0 | 112 |
| Completed | 205 | 0 | 109 |
| Not completed | 17 | 0 | 3 |
Patients with at least a 1.2 mg/dL decrease in serum phosphorus during the first 26 weeks of the study were defined as the responder population.
| mg/dL | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate |
|---|---|---|---|
| Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the Responder Population | 0.43 ± 0.199 | 1.80 ± 0.196 | — |
Placebo Adjusted Change in Serum Phosphorus from the beginning to the end of the Randomized Withdrawal Period in all patients
| mg/dL | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate |
|---|---|---|---|
| Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the ITT Population | 0.22 ± 0.149 | 0.88 ± 0.150 | — |
Serum Phosphorus from baseline (post washout) to end of 26 week period
| mg/dL | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate |
|---|---|---|---|
| Baseline Serum Phosphorus | 7.44 ± 1.439 | — | — |
| End of Period serum Phosphorus | 5.88 ± 1,455 | — | — |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tenapanor 10 mg, 20 mg, 30 mg BID | 12/419 (2.9%) | 47/419 (11.2%) | 222/419 (53%) |
| Placebo | 1/126 (0.8%) | 4/126 (3.2%) | 2/126 (1.6%) |
| Sevelamer Carbonate | 5/137 (3.6%) | 39/137 (28.5%) | 10/137 (7.3%) |
| Event | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate |
|---|---|---|---|
| pneumoniaInfections and infestations | 6/419 | 0/126 | 8/137 |
| Acute Myocardial InfarctionCardiac disorders | 3/419 | 0/126 | 7/137 |
| Fluid OverloadMetabolism and nutrition disorders | 7/419 | 1/126 | 6/137 |
| CellulitisInfections and infestations | 6/419 | 1/126 | 5/137 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 8/419 | 1/126 | 5/137 |
| HyperkalemiaMetabolism and nutrition disorders | 5/419 | 0/126 | 5/137 |
| SepsisInfections and infestations | 6/419 | 1/126 | 2/137 |
| Atrial FibrillationCardiac disorders | 6/419 | 0/126 | 1/137 |
| Event | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate |
|---|---|---|---|
| DiarrheaGastrointestinal disorders | 222/419 | 2/126 | 10/137 |
Placebo was only used in the randomized withdrawal period (RWP). In the RWP, patients from the tenapanor (TEN) group were randomized 1:1 to either remain on TEN or receive a matching placebo. The patients on Sevelamer were not included in this part of the protocol.
| Age, Continuous(years) | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate | Total |
|---|---|---|---|---|
| Mean | 57.74 ± 12.639 | — | 59.00 ± 12.638 | 58.05 ± 12.639 |
| Sex: Female, Male(Participants) | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate | Total |
|---|---|---|---|---|
| Female | 154 | — | 46 | 200 |
| Male | 265 | — | 91 | 356 |
| Ethnicity (NIH/OMB)(Participants) | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate | Total |
|---|---|---|---|---|
| Hispanic or Latino | 115 | — | 41 | 156 |
| Not Hispanic or Latino | 302 | — | 96 | 398 |
| Unknown or Not Reported | 2 | — | 0 | 2 |
| Race (NIH/OMB)(Participants) | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 11 | — | 0 | 11 |
| Asian | 21 | — | 7 | 28 |
| Native Hawaiian or Other Pacific Islander | 2 | — | 0 | 2 |
| Black or African American | 195 | — | 60 | 255 |
| White | 189 | — | 70 | 259 |
| More than one race | 0 | — | 0 | 0 |
| Unknown or Not Reported | 1 | — | 0 | 1 |
| BMI(kg/m^2) | Tenapanor 10 mg, 20 mg, 30 mg BID | Placebo | Sevelamer Carbonate | Total |
|---|---|---|---|---|
| Mean | 31.30 ± 7.505 | — | 31.41 ± 9.918 | 31.33 ± 8.159 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2018 to primary completion in Nov 2019, 22 months.
Results were first posted in Jun 2023, 3 years 7 months after primary completion. A results delay was requested in Aug 2020.
Of 21 phase 3 interventional studies under Hyperphosphatemia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 22. This study's 22 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tenapanor