Trial · NCT03824587

Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

NCT03824587, Phase 2, Phase 3, Completed, Ardelyx; results first posted 2023-03-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy. Trials, record NCT03824587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03824587

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy
NCT number: NCT03824587
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 236 participants, actual
Lead sponsor: Ardelyx
Conditions: Hyperphosphatemia
Interventions: Tenapanor, Placebo, Phosphate Binder Agents
First posted: 2019-01-31
Last updated: 2023-03-06
Results first posted: 2023-03-06

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.	4 Weeks (28 days randomization period; from baseline to week 4)	Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.
Secondary	s-P Response at Week 4	4 Weeks (28 days randomization period)	Achieving an s-P level \<5.5 mg/dL
Secondary	Relative Change From Baseline in iFGF23 at Week 4	4 Weeks (28 days randomization period)	iFGF23 at Week 4/baseline iFGF23 - 1
Secondary	Relative Change From Baseline in cFGF23 at Week 4	4 Weeks (28 days randomization period)	cFGF23 at Week 4/baseline cFGF23 - 1

Source ClinicalTrials.gov

Outcomes4

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 (s-P) Level From Baseline to Week 4.	4 Weeks (28 days randomization period; from baseline to week 4)	One patient did not receive study drug so was therefore not included in the modified ITT analysis	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	s-P Response at Week 4	4 Weeks (28 days randomization period)	One patient did not receive study drug so was therefore not included in the modified ITT analysis	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Relative Change From Baseline in iFGF23 at Week 4	4 Weeks (28 days randomization period)	One patient did not receive study drug so was therefore not included in the modified ITT analysis	pg/mL	GEOMETRIC_LEAST_SQUARES_MEAN
SECONDARY	Relative Change From Baseline in cFGF23 at Week 4	4 Weeks (28 days randomization period)	One patient did not receive study drug so was therefore not included in the modified ITT analysis	pg/mL	GEOMETRIC_LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.	Tenapanor 30 mg BID	-0.84	Standard Error 0.131	mg/dL
Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.	Placebo	-0.19	Standard Error 0.130	mg/dL
s-P Response at Week 4	Tenapanor 30 mg BID	43		Participants
s-P Response at Week 4	Placebo	26		Participants
Relative Change From Baseline in iFGF23 at Week 4	Tenapanor 30 mg BID	0.756	95% Confidence Interval 0.686 to 0.834	pg/mL
Relative Change From Baseline in iFGF23 at Week 4	Placebo	0.931	95% Confidence Interval 0.845 to 1.025	pg/mL
Relative Change From Baseline in cFGF23 at Week 4	Tenapanor 30 mg BID	0.779	95% Confidence Interval 0.716 to 0.848	pg/mL
Relative Change From Baseline in cFGF23 at Week 4	Placebo	0.947	95% Confidence Interval 0.871 to 1.030	pg/mL

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Run-in Period	STARTED	Tenapanor 30 mg BID	0
Run-in Period	STARTED	Placebo	511
Run-in Period	COMPLETED	Tenapanor 30 mg BID	0
Run-in Period	COMPLETED	Placebo	236
Run-in Period	NOT COMPLETED	Tenapanor 30 mg BID	0
Run-in Period	NOT COMPLETED	Placebo	275
Treatment Period	STARTED	Tenapanor 30 mg BID	117
Treatment Period	STARTED	Placebo	119
Treatment Period	COMPLETED	Tenapanor 30 mg BID	112
Treatment Period	COMPLETED	Placebo	116

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events16

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
other	Diarrhea	Gastrointestinal disorders	Tenapanor 30 mg BID	50	117
other	Diarrhea	Gastrointestinal disorders	Placebo	8	119
serious	Acute Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	Tenapanor 30 mg BID	1	117
serious	Acute Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	Placebo	1	119
serious	Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Tenapanor 30 mg BID	0	117
serious	Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	Placebo	1	119
serious	Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	Tenapanor 30 mg BID	1	117
serious	Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	Placebo	0	119
serious	Cardiorespiratory Arrest	Cardiac disorders	Tenapanor 30 mg BID	1	117
serious	Cardiorespiratory Arrest	Cardiac disorders	Placebo	0	119

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tenapanor 30 mg BID	0	117
Total, all-cause mortality	Placebo	0	119
Total, other adverse events	Tenapanor 30 mg BID	50	117
Total, other adverse events	Placebo	8	119
Total, serious adverse events	Tenapanor 30 mg BID	3	117
Total, serious adverse events	Placebo	5	119

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33766811	DERIVED	PubMed
38323855	DERIVED	PubMed

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 comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tenapanor 30 mg BID vs Placebo: s-P Response at Week 4	Trial comparisons
Tenapanor 30 mg BID vs Placebo: deaths from any cause	Trial comparisons
Tenapanor 30 mg BID vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03824587

GET https://conductscience.org/api/trials/v1/NCT03824587/registered

API reference For AI assistants