A Phase 2/3 interventional study of Tenapanor and Placebo in Hyperphosphatemia, sponsored by Ardelyx. Completed at 48 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-06.
Sponsored by Ardelyx · Phase 2/3, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy.
The study consists of a Screening visit; a Run-in Period of at least 2 weeks and up to 4 weeks, where existing phosphate binder treatment is maintained; and a 4-week Double-Blind Treatment Period.
At Screening, a subject must be on thrice daily phosphate binder therapy and have a serum phosphate (s-P) level ≥5.5 and ≤10.0 mg/dL to qualify for entering the study. s-P will be measured at each visit during the run-in period to enable the evaluation of the s-P randomization criteria.
Subjects who qualify to enroll in the study will be randomized in a 1:1 ratio to receive tenapanor or placebo while continuing their existing phosphate binder treatment.
During the Double-Blind Treatment Period, subjects will receive tenapanor or placebo starting at a dose of 30 mg bid
173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.
This study's enrollment of 236 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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time). Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.
Drug: Tenapanor · Drug: Phosphate Binder Agents
same size, weight and appearance of experimental drug
Drug: Placebo · Drug: Phosphate Binder Agents
Active Drug
Inactive Drug
standard of care phosphate binder use at study entry was maintained throughout the entire study
Also known as: sevelamer carbonate, ferric citrate, calcium carbonate, calcium acetate, sucroferric oxyhydroxide
Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.
Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.
Time frame: 4 Weeks (28 days randomization period; from baseline to week 4)
s-P Response at Week 4
Achieving an s-P level \<5.5 mg/dL
Time frame: 4 Weeks (28 days randomization period)
Relative Change From Baseline in iFGF23 at Week 4
iFGF23 at Week 4/baseline iFGF23 - 1
Time frame: 4 Weeks (28 days randomization period)
Relative Change From Baseline in cFGF23 at Week 4
cFGF23 at Week 4/baseline cFGF23 - 1
Time frame: 4 Weeks (28 days randomization period)
| Milestone | Tenapanor 30 mg BID | Placebo |
|---|---|---|
| Started | 0 | 511 |
| Completed | 0 | 236 |
| Not completed | 0 | 275 |
| Withdrew: Screen failure | 0 | 275 |
| Milestone | Tenapanor 30 mg BID | Placebo |
|---|---|---|
| Started | 117 | 119 |
| Completed | 112 | 116 |
| Not completed | 5 | 3 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Kidney transplant | 1 | 1 |
Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.
| mg/dL | Tenapanor 30 mg BID | Placebo |
|---|---|---|
| Change in Serum Phosphorus (s-P) Level From Baseline to Week 4. | -0.84 ± 0.131 | -0.19 ± 0.130 |
Achieving an s-P level \<5.5 mg/dL
| Participants | Tenapanor 30 mg BID | Placebo |
|---|---|---|
| s-P Response at Week 4 | 43 | 26 |
iFGF23 at Week 4/baseline iFGF23 - 1
| pg/mL | Tenapanor 30 mg BID | Placebo |
|---|---|---|
| Relative Change From Baseline in iFGF23 at Week 4 | 0.756 (0.686 to 0.834) | 0.931 (0.845 to 1.025) |
cFGF23 at Week 4/baseline cFGF23 - 1
| pg/mL | Tenapanor 30 mg BID | Placebo |
|---|---|---|
| Relative Change From Baseline in cFGF23 at Week 4 | 0.779 (0.716 to 0.848) | 0.947 (0.871 to 1.030) |
Collected over Adverse events were collected for the 4 week (28 days) treatment period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tenapanor 30 mg BID | 0/117 (0%) | 3/117 (2.6%) | 50/117 (42.7%) |
| Placebo | 0/119 (0%) | 5/119 (4.2%) | 8/119 (6.7%) |
| Event | Tenapanor 30 mg BID | Placebo |
|---|---|---|
| Acute Pulmonary EdemaRespiratory, thoracic and mediastinal disorders | 1/117 | 1/119 |
| Pulmonary EdemaRespiratory, thoracic and mediastinal disorders | 1/117 | 0/119 |
| Cardiorespiratory ArrestCardiac disorders | 1/117 | 0/119 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 0/117 | 1/119 |
| Nodal ArrhythmiaCardiac disorders | 0/117 | 1/119 |
| Arteriovenous Fistula AneurysmInjury, poisoning and procedural complications | 0/117 | 1/119 |
| PneumoniaInfections and infestations | 0/117 | 1/119 |
| Event | Tenapanor 30 mg BID | Placebo |
|---|---|---|
| DiarrheaGastrointestinal disorders | 50/117 | 8/119 |
| Age, Continuous(years) | Tenapanor 30 mg BID | Placebo | Total |
|---|---|---|---|
| Mean | 55.10 ± 12.326 | 53.88 ± 12.673 | 54.49 ± 12.491 |
| Sex: Female, Male(Participants) | Tenapanor 30 mg BID | Placebo | Total |
|---|---|---|---|
| Female | 52 | 45 | 97 |
| Male | 65 | 74 | 139 |
| Ethnicity (NIH/OMB)(Participants) | Tenapanor 30 mg BID | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 37 | 30 | 67 |
| Not Hispanic or Latino | 79 | 88 | 167 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Tenapanor 30 mg BID | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 1 | 5 |
| Asian | 2 | 4 | 6 |
| Native Hawaiian or Other Pacific Islander | 1 | 2 | 3 |
| Black or African American | 52 | 50 | 102 |
| White | 57 | 60 | 117 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Serum Phosphorus < 7.5 mg/dL(Participants) | Tenapanor 30 mg BID | Placebo | Total |
|---|---|---|---|
| Count of participants | 76 | 77 | 153 |
| Serum Phosphorus >= 7.5 mg/d:(Participants) | Tenapanor 30 mg BID | Placebo | Total |
|---|---|---|---|
| Count of participants | 41 | 42 | 83 |
| Sevelamer(Participants) | Tenapanor 30 mg BID | Placebo | Total |
|---|---|---|---|
| Count of participants | 57 | 58 | 115 |
| Non-Sevelamer(Participants) | Tenapanor 30 mg BID | Placebo | Total |
|---|---|---|---|
| Count of participants | 60 | 61 | 121 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tenapanor