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Trial · NCT01847092

A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

NCT01847092, Phase 2, Completed, Ardelyx; results first posted 2020-05-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria. Trials, record NCT01847092. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01847092

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Trial

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

Title
A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
NCT number
NCT01847092
Status
Completed
Phases
Phase 2
Enrollment
154 participants, actual
Lead sponsor
Ardelyx
Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Interventions
AZD1722, Placebo
First posted
2013-05-06
Last updated
2020-05-27
Results first posted
2020-05-27

Source ClinicalTrials.gov

Registered outcomes2

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

ListOutcomeTime frameDescription
PrimaryChanges in Urine Albumin to Creatinine Ratio (UACR)Week 12The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment
SecondaryChange in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint12 weeks

Outcomes2

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChanges in Urine Albumin to Creatinine Ratio (UACR)Week 12mg/gMEAN
SECONDARYChange in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint12 weeksmL/min/1.73 m2LEAST_SQUARES_MEAN

Results by group4

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

OutcomeGroupCategoryValueSpreadUnits
Changes in Urine Albumin to Creatinine Ratio (UACR)AZD1722-64.6Standard Deviation 898.4mg/g
Changes in Urine Albumin to Creatinine Ratio (UACR)Placebo104.8Standard Deviation 668.0mg/g
Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 EndpointAZD1722-2.8Standard Deviation 1.21mL/min/1.73 m2
Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 EndpointPlacebo-2.7Standard Deviation 1.19mL/min/1.73 m2

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDAZD172277
Overall StudySTARTEDPlacebo77
Overall StudyCOMPLETEDAZD172251
Overall StudyCOMPLETEDPlacebo66
Overall StudyNOT COMPLETEDAZD172226
Overall StudyNOT COMPLETEDPlacebo11

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDiarrheaGastrointestinal disordersAZD1722457745
otherDiarrheaGastrointestinal disordersPlacebo4774
seriousHyperkalemiaInvestigationsAZD17222772
seriousHyperkalemiaInvestigationsPlacebo1771
seriousDeep Vein ThrombosisBlood and lymphatic system disordersAZD17221771
seriousDeep Vein ThrombosisBlood and lymphatic system disordersPlacebo0770
seriousCardiac failure congestiveCardiac disordersAZD17220770
seriousCardiac failure congestiveCardiac disordersPlacebo1771

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityAZD1722077
Total, all-cause mortalityPlacebo077
Total, other adverse eventsAZD17224577
Total, other adverse eventsPlacebo477
Total, serious adverse eventsAZD1722377
Total, serious adverse eventsPlacebo277

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 comparisons2

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

ComparisonSource
AZD1722 vs Placebo: deaths from any causeTrial comparisons
AZD1722 vs Placebo: serious adverse eventsTrial 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/NCT01847092

GET https://conductscience.org/api/trials/v1/NCT01847092/registered