Trial · NCT01764854

Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis

NCT01764854, Phase 2, Completed, Ardelyx; results first posted 2020-08-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis. Trials, record NCT01764854. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01764854

On this page

Trial

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

Title: Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
NCT number: NCT01764854
Status: Completed
Phases: Phase 2
Enrollment: 88 participants, actual
Lead sponsor: Ardelyx
Conditions: End Stage Renal Disease, Chronic Kidney Disease Stage 5, ESRD
Interventions: AZD1722 (in-patient), Placebo (in-patient), AZD1722 (out-patient), Placebo
First posted: 2013-01-10
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	Change in Mean Weekly Interdialytic Weight Gain (IDWG)	Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)	Patients are weighed pre dialysis prior to their first dialysis of the week. This measure looks at the change in pre-dialysis weight over time
Secondary	Stool Sodium Content	Days 1 through 7	The amount of sodium in a days worth of stool output

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	Change in Mean Weekly Interdialytic Weight Gain (IDWG)	Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)	The out-patient arms were the only groups that were pre-specified to be included in this analysis since the in-patient arms were only treated for one week.	kilograms	MEAN
SECONDARY	Stool Sodium Content	Days 1 through 7	The in-patient arms were the only groups pre-specified to be used in this analysis since stool could only be collected in the clinical pharmacology unit (in-patient).	mEq/day	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Change in Mean Weekly Interdialytic Weight Gain (IDWG)	AZD1722 Out-patient	-0.26	Standard Deviation 0.939	kilograms
Change in Mean Weekly Interdialytic Weight Gain (IDWG)	Placebo Out-patient	-0.23	Standard Deviation 0.871	kilograms
Stool Sodium Content	AZD1722- in Patient	36.62	Standard Deviation 21.809	mEq/day
Stool Sodium Content	Placebo- in Patient	2.82	Standard Deviation 2.655	mEq/day

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AZD1722- in Patient	8
Overall Study	STARTED	Placebo- in Patient	8
Overall Study	STARTED	AZD1722 Out-patient	37
Overall Study	STARTED	Placebo Out-patient	35
Overall Study	COMPLETED	AZD1722- in Patient	8
Overall Study	COMPLETED	Placebo- in Patient	8
Overall Study	COMPLETED	AZD1722 Out-patient	31
Overall Study	COMPLETED	Placebo Out-patient	33
Overall Study	NOT COMPLETED	AZD1722- in Patient	0
Overall Study	NOT COMPLETED	Placebo- in Patient	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events24

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	AZD1722- in Patient	6	8	6
other	diarrhea	Gastrointestinal disorders	Placebo- in Patient	2	8	2
other	diarrhea	Gastrointestinal disorders	AZD1722 Out-patient	3	37	3
other	diarrhea	Gastrointestinal disorders	Placebo Out-patient	21	35	21
serious	Syncope	Cardiac disorders	AZD1722- in Patient	0	8	0
serious	Syncope	Cardiac disorders	Placebo- in Patient	1	8	1
serious	Syncope	Cardiac disorders	AZD1722 Out-patient	1	37	1
serious	Syncope	Cardiac disorders	Placebo Out-patient	0	35	0
serious	Urinary Tract Infection	Renal and urinary disorders	AZD1722- in Patient	0	8	0
serious	Urinary Tract Infection	Renal and urinary disorders	Placebo- in Patient	0	8	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AZD1722- in Patient	0	8
Total, all-cause mortality	Placebo- in Patient	0	8
Total, all-cause mortality	AZD1722 Out-patient	0	37
Total, all-cause mortality	Placebo Out-patient	0	35
Total, other adverse events	AZD1722- in Patient	6	8
Total, other adverse events	Placebo- in Patient	2	8
Total, other adverse events	AZD1722 Out-patient	3	37
Total, other adverse events	Placebo Out-patient	21	35
Total, serious adverse events	AZD1722- in Patient	0	8
Total, serious adverse events	Placebo- in Patient	3	8

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT01764854

GET https://conductscience.org/api/trials/v1/NCT01764854/events?page=2

API reference For AI assistants