Trial · NCT03427125
A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis
NCT03427125, Phase 3, Completed, Ardelyx; results first posted 2023-06-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis. Trials, record NCT03427125. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03427125
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis
- NCT number
- NCT03427125
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,559 participants, actual
- Lead sponsor
- Ardelyx
- Conditions
- Hyperphosphatemia
- Interventions
- Tenapanor, Placebo, Sevelamer Carbonate
- First posted
- 2018-02-09
- Last updated
- 2023-06-29
- Results first posted
- 2023-06-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the Responder Population | 12 weeks (randomized withdrawal period) | 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. |
| Secondary | Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the ITT Population | 12 weeks (randomized withdrawal period) | Placebo Adjusted Change in Serum Phosphorus from the beginning to the end of the Randomized Withdrawal Period in all patients |
| Secondary | Serum Phosphorus From Baseline | 26 weeks (open label treatment period) | Serum Phosphorus from baseline (post washout) to end of 26 week period |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the Responder Population | 12 weeks (randomized withdrawal period) | The sevalmer arm was not included in the randomized withdrawal period. They were treated as an active safety comparator. | mg/dL | MEAN |
| SECONDARY | Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the ITT Population | 12 weeks (randomized withdrawal period) | The sevelamer group did not participate in the randomized withdrawal period | mg/dL | MEAN |
| SECONDARY | Serum Phosphorus From Baseline | 26 weeks (open label treatment period) | There were no placebo during this period and the sevelamer arm was a safety comparator only | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the Responder Population | Tenapanor 10 mg, 20 mg, 30 mg BID | 0.43 | Standard Deviation 0.199 | mg/dL | |
| Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the Responder Population | Placebo | 1.80 | Standard Deviation 0.196 | mg/dL | |
| Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the ITT Population | Tenapanor 10 mg, 20 mg, 30 mg BID | 0.22 | Standard Deviation 0.149 | mg/dL | |
| Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the ITT Population | Placebo | 0.88 | Standard Deviation 0.150 | mg/dL | |
| Serum Phosphorus From Baseline | Tenapanor 10 mg, 20 mg, 30 mg BID | Baseline Serum Phosphorus | 7.44 | Standard Deviation 1.439 | mg/dL |
| Serum Phosphorus From Baseline | Tenapanor 10 mg, 20 mg, 30 mg BID | End of Period serum Phosphorus | 5.88 | Standard Deviation 1,455 | mg/dL |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 2 to 4 Week Washout Period | STARTED | Tenapanor 10 mg, 20 mg, 30 mg BID | 0 | |
| 2 to 4 Week Washout Period | STARTED | Placebo | 1,559 | |
| 2 to 4 Week Washout Period | STARTED | Sevelamer Carbonate | 0 | |
| 2 to 4 Week Washout Period | COMPLETED | Tenapanor 10 mg, 20 mg, 30 mg BID | 0 | |
| 2 to 4 Week Washout Period | COMPLETED | Placebo | 564 | |
| 2 to 4 Week Washout Period | COMPLETED | Sevelamer Carbonate | 0 | |
| 2 to 4 Week Washout Period | NOT COMPLETED | Tenapanor 10 mg, 20 mg, 30 mg BID | 0 | |
| 2 to 4 Week Washout Period | NOT COMPLETED | Placebo | 995 | |
| 2 to 4 Week Washout Period | NOT COMPLETED | Sevelamer Carbonate | 0 | |
| 26-Week Treatment Period | STARTED | Tenapanor 10 mg, 20 mg, 30 mg BID | 423 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Tenapanor 10 mg, 20 mg, 30 mg BID | 222 | 419 | 222 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 2 | 126 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Sevelamer Carbonate | 10 | 137 | 10 |
| serious | pneumonia | Infections and infestations | Tenapanor 10 mg, 20 mg, 30 mg BID | 6 | 419 | 6 |
| serious | pneumonia | Infections and infestations | Placebo | 0 | 126 | 0 |
| serious | pneumonia | Infections and infestations | Sevelamer Carbonate | 8 | 137 | 8 |
| serious | Cellulitis | Infections and infestations | Tenapanor 10 mg, 20 mg, 30 mg BID | 6 | 419 | 6 |
| serious | Cellulitis | Infections and infestations | Placebo | 1 | 126 | 1 |
| serious | Cellulitis | Infections and infestations | Sevelamer Carbonate | 5 | 137 | 5 |
| serious | Sepsis | Infections and infestations | Tenapanor 10 mg, 20 mg, 30 mg BID | 6 | 419 | 6 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tenapanor 10 mg, 20 mg, 30 mg BID | 12 | 419 |
| Total, all-cause mortality | Placebo | 1 | 126 |
| Total, all-cause mortality | Sevelamer Carbonate | 5 | 137 |
| Total, other adverse events | Tenapanor 10 mg, 20 mg, 30 mg BID | 222 | 419 |
| Total, other adverse events | Placebo | 2 | 126 |
| Total, other adverse events | Sevelamer Carbonate | 10 | 137 |
| Total, serious adverse events | Tenapanor 10 mg, 20 mg, 30 mg BID | 47 | 419 |
| Total, serious adverse events | Placebo | 4 | 126 |
| Total, serious adverse events | Sevelamer Carbonate | 39 | 137 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03427125
GET https://conductscience.org/api/trials/v1/NCT03427125/flow?page=2