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Trial · NCT02081534

Dose Finding Study to Treat High Phosphate Levels in the Blood.

NCT02081534, Phase 2, Completed, Ardelyx; results first posted 2020-09-14

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Dose Finding Study to Treat High Phosphate Levels in the Blood. Trials, record NCT02081534. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02081534

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Trial

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

Title
Dose Finding Study to Treat High Phosphate Levels in the Blood.
NCT number
NCT02081534
Status
Completed
Phases
Phase 2
Enrollment
162 participants, actual
Lead sponsor
Ardelyx
Conditions
Hyperphosphatemia
Interventions
AZD1722, Placebo
First posted
2014-03-07
Last updated
2020-09-14
Results first posted
2020-09-14

Source ClinicalTrials.gov

Registered outcomes2

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

ListOutcomeTime frameDescription
PrimaryChange in Serum Phosphate LevelsEnd of wash out (pre randomization value) to end of treatment (Day 29)Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment
SecondaryChange From Baseline in Calcium x Phosphorus ProductEnd of wash out (pre randomization value) to end of treatment (Day 29)Change from baseline (end of wash out) in calcium x phosphorus product

Outcomes2

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Serum Phosphate LevelsEnd of wash out (pre randomization value) to end of treatment (Day 29)two patients in the 30 mg bid group are not included in the analysis since they had no post randomization serum phosphorus measurementsmg/dLLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Calcium x Phosphorus ProductEnd of wash out (pre randomization value) to end of treatment (Day 29)The number of patients analyzed are less than the randomized number since the data to accomplish the analysis was not available.mg/dL * mg/dLMEAN

Results by group14

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

OutcomeGroupCategoryValueSpreadUnits
Change in Serum Phosphate Levels1 mg Bid-.47Standard Deviation 1.553mg/dL
Change in Serum Phosphate Levels3 mg Bid-1.18Standard Deviation 1.391mg/dL
Change in Serum Phosphate Levels10 mg Bid-1.7Standard Deviation 2.018mg/dL
Change in Serum Phosphate Levels30 mg Bid-1.98Standard Deviation 2.007mg/dL
Change in Serum Phosphate Levels3 mg od-.56Standard Deviation 1.763mg/dL
Change in Serum Phosphate Levels30 mg od-1.11Standard Deviation 1.469mg/dL
Change in Serum Phosphate LevelsPlacebo-.54Standard Deviation 1.802mg/dL
Change From Baseline in Calcium x Phosphorus Product1 mg Bid-5.16Standard Deviation 9.75mg/dL * mg/dL
Change From Baseline in Calcium x Phosphorus Product3 mg Bid-12.02Standard Deviation 14.02mg/dL * mg/dL
Change From Baseline in Calcium x Phosphorus Product10 mg Bid-12.44Standard Deviation 15.94mg/dL * mg/dL

Participant flow21

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTED1 mg Bid23
Overall StudySTARTED3 mg Bid21
Overall StudySTARTED10 mg Bid23
Overall StudySTARTED30 mg Bid26
Overall StudySTARTED3 mg od22
Overall StudySTARTED30 mg od21
Overall StudySTARTEDPlacebo26
Overall StudyCOMPLETED1 mg Bid18
Overall StudyCOMPLETED3 mg Bid13
Overall StudyCOMPLETED10 mg Bid19

Adverse events98

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDiarrheaGastrointestinal disorders1 mg Bid6236
otherDiarrheaGastrointestinal disorders3 mg Bid6216
otherDiarrheaGastrointestinal disorders10 mg Bid112311
otherDiarrheaGastrointestinal disorders30 mg Bid172617
otherDiarrheaGastrointestinal disorders3 mg od4224
otherDiarrheaGastrointestinal disorders30 mg od112111
otherDiarrheaGastrointestinal disordersPlacebo3263
seriousChest painCardiac disorders1 mg Bid1231
seriousChest painCardiac disorders3 mg Bid0210
seriousChest painCardiac disorders10 mg Bid0230

Adverse event totals21

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortality1 mg Bid123
Total, all-cause mortality3 mg Bid021
Total, all-cause mortality10 mg Bid023
Total, all-cause mortality30 mg Bid026
Total, all-cause mortality3 mg od022
Total, all-cause mortality30 mg od021
Total, all-cause mortalityPlacebo026
Total, other adverse events1 mg Bid623
Total, other adverse events3 mg Bid621
Total, other adverse events10 mg Bid1123

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
29617976DERIVEDPubMed
38323855DERIVEDPubMed

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/NCT02081534

GET https://conductscience.org/api/trials/v1/NCT02081534/flow?page=2