Trial · NCT02675998

An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

NCT02675998, Phase 3, Completed, Ardelyx; results first posted 2020-08-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD). Trials, record NCT02675998. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02675998

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Trial

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

Title: An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
NCT number: NCT02675998
Status: Completed
Phases: Phase 3
Enrollment: 219 participants, actual
Lead sponsor: Ardelyx
Conditions: Hyperphosphatemia
Interventions: Tenapanor, Placebo
First posted: 2016-02-05
Last updated: 2020-08-10
Results first posted: 2020-08-10

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor Arms	4 weeks	Serum phosphorus difference between placebo and tenapanor in the change from the end of the 8 week treatment period to the end of the randomized withdrawal period in Efficacy Analysis Set. The efficacy analysis was pre-defined to be a pooled analysis of all tenapanor treated patients with a minimum of a 1.2 mg/dL decrease in serum phosphorus during the 8-week treatment period
Secondary	Change in Serum Phosphate During 8-Week Treatment Period	Baseline and 8 weeks	Serum phosphorus difference between baseline (end of washout period) to the end of the 8 week treatment period in ITT analysis set

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor Arms	4 weeks	Patients who completed the first 8-weeks and had a minimum of a 1.2 mg/dL decrease in serum phosphorus were included in the analysis. Also, it was a pre-specificied pooled analysis where all the tenapanor treated patients were combined thus all patients are included in the 30 mg dose titration group.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change in Serum Phosphate During 8-Week Treatment Period	Baseline and 8 weeks	There was no placebo group during the 8-week treatment period.	mg/dL	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Value	Spread	Units
Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor Arms	30 mg Dose Titration	1.4	Standard Error 0.23	mg/dL
Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor Arms	Placebo	0.6	Standard Error 0.21	mg/dL
Change in Serum Phosphate During 8-Week Treatment Period	3mg BID	-1.1	Standard Error 0.17	mg/dL
Change in Serum Phosphate During 8-Week Treatment Period	10mg BID	-1.1	Standard Error 0.17	mg/dL
Change in Serum Phosphate During 8-Week Treatment Period	30 mg Dose Titration	-1.1	Standard Error 0.18	mg/dL

Source ClinicalTrials.gov

Participant flow24

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

Period	Milestone	Group	Participants
8-Week Treatment Period	STARTED	3mg BID	74
8-Week Treatment Period	STARTED	10mg BID	73
8-Week Treatment Period	STARTED	30 mg Dose Titration	72
8-Week Treatment Period	STARTED	Randomized Withdrawal Period Placebo	0
8-Week Treatment Period	COMPLETED	3mg BID	57
8-Week Treatment Period	COMPLETED	10mg BID	54
8-Week Treatment Period	COMPLETED	30 mg Dose Titration	53
8-Week Treatment Period	COMPLETED	Randomized Withdrawal Period Placebo	0
8-Week Treatment Period	NOT COMPLETED	3mg BID	17
8-Week Treatment Period	NOT COMPLETED	10mg BID	19

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events8

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	3mg BID	22	74	22
other	Diarrhea	Gastrointestinal disorders	10mg BID	30	73	30
other	Diarrhea	Gastrointestinal disorders	30 mg Dose Titration	34	72	34
other	Diarrhea	Gastrointestinal disorders	Randomized Withdrawal Period Placebo	7	82	7
serious	Diarrhea	Gastrointestinal disorders	3mg BID	1	74	1
serious	Diarrhea	Gastrointestinal disorders	10mg BID	0	73
serious	Diarrhea	Gastrointestinal disorders	30 mg Dose Titration	0	72
serious	Diarrhea	Gastrointestinal disorders	Randomized Withdrawal Period Placebo	0	82

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	3mg BID	1	74
Total, all-cause mortality	10mg BID	0	73
Total, all-cause mortality	30 mg Dose Titration	0	72
Total, all-cause mortality	Randomized Withdrawal Period Placebo	0	82
Total, other adverse events	3mg BID	22	74
Total, other adverse events	10mg BID	30	73
Total, other adverse events	30 mg Dose Titration	34	72
Total, other adverse events	Randomized Withdrawal Period Placebo	7	82
Total, serious adverse events	3mg BID	1	74
Total, serious adverse events	10mg BID	0	73

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
37853560	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 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.

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/NCT02675998

GET https://conductscience.org/api/trials/v1/NCT02675998/flow?page=2

API reference For AI assistants