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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Serum Phosphate Levels | End 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 |
| Secondary | Change From Baseline in Calcium x Phosphorus Product | End of wash out (pre randomization value) to end of treatment (Day 29) | Change from baseline (end of wash out) in calcium x phosphorus product |
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 Serum Phosphate Levels | End 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 measurements | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Calcium x Phosphorus Product | End 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/dL | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Serum Phosphate Levels | 1 mg Bid | -.47 | Standard Deviation 1.553 | mg/dL | |
| Change in Serum Phosphate Levels | 3 mg Bid | -1.18 | Standard Deviation 1.391 | mg/dL | |
| Change in Serum Phosphate Levels | 10 mg Bid | -1.7 | Standard Deviation 2.018 | mg/dL | |
| Change in Serum Phosphate Levels | 30 mg Bid | -1.98 | Standard Deviation 2.007 | mg/dL | |
| Change in Serum Phosphate Levels | 3 mg od | -.56 | Standard Deviation 1.763 | mg/dL | |
| Change in Serum Phosphate Levels | 30 mg od | -1.11 | Standard Deviation 1.469 | mg/dL | |
| Change in Serum Phosphate Levels | Placebo | -.54 | Standard Deviation 1.802 | mg/dL | |
| Change From Baseline in Calcium x Phosphorus Product | 1 mg Bid | -5.16 | Standard Deviation 9.75 | mg/dL * mg/dL | |
| Change From Baseline in Calcium x Phosphorus Product | 3 mg Bid | -12.02 | Standard Deviation 14.02 | mg/dL * mg/dL | |
| Change From Baseline in Calcium x Phosphorus Product | 10 mg Bid | -12.44 | Standard Deviation 15.94 | mg/dL * mg/dL |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1 mg Bid | 23 | |
| Overall Study | STARTED | 3 mg Bid | 21 | |
| Overall Study | STARTED | 10 mg Bid | 23 | |
| Overall Study | STARTED | 30 mg Bid | 26 | |
| Overall Study | STARTED | 3 mg od | 22 | |
| Overall Study | STARTED | 30 mg od | 21 | |
| Overall Study | STARTED | Placebo | 26 | |
| Overall Study | COMPLETED | 1 mg Bid | 18 | |
| Overall Study | COMPLETED | 3 mg Bid | 13 | |
| Overall Study | COMPLETED | 10 mg Bid | 19 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events98
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 | 1 mg Bid | 6 | 23 | 6 |
| other | Diarrhea | Gastrointestinal disorders | 3 mg Bid | 6 | 21 | 6 |
| other | Diarrhea | Gastrointestinal disorders | 10 mg Bid | 11 | 23 | 11 |
| other | Diarrhea | Gastrointestinal disorders | 30 mg Bid | 17 | 26 | 17 |
| other | Diarrhea | Gastrointestinal disorders | 3 mg od | 4 | 22 | 4 |
| other | Diarrhea | Gastrointestinal disorders | 30 mg od | 11 | 21 | 11 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 3 | 26 | 3 |
| serious | Chest pain | Cardiac disorders | 1 mg Bid | 1 | 23 | 1 |
| serious | Chest pain | Cardiac disorders | 3 mg Bid | 0 | 21 | 0 |
| serious | Chest pain | Cardiac disorders | 10 mg Bid | 0 | 23 | 0 |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 mg Bid | 1 | 23 |
| Total, all-cause mortality | 3 mg Bid | 0 | 21 |
| Total, all-cause mortality | 10 mg Bid | 0 | 23 |
| Total, all-cause mortality | 30 mg Bid | 0 | 26 |
| Total, all-cause mortality | 3 mg od | 0 | 22 |
| Total, all-cause mortality | 30 mg od | 0 | 21 |
| Total, all-cause mortality | Placebo | 0 | 26 |
| Total, other adverse events | 1 mg Bid | 6 | 23 |
| Total, other adverse events | 3 mg Bid | 6 | 21 |
| Total, other adverse events | 10 mg Bid | 11 | 23 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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