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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Urine Albumin to Creatinine Ratio (UACR) | Week 12 | The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment |
| Secondary | Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint | 12 weeks |
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 | Changes in Urine Albumin to Creatinine Ratio (UACR) | Week 12 | mg/g | MEAN | |
| SECONDARY | Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint | 12 weeks | mL/min/1.73 m2 | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Urine Albumin to Creatinine Ratio (UACR) | AZD1722 | -64.6 | Standard Deviation 898.4 | mg/g | |
| Changes in Urine Albumin to Creatinine Ratio (UACR) | Placebo | 104.8 | Standard Deviation 668.0 | mg/g | |
| Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint | AZD1722 | -2.8 | Standard Deviation 1.21 | mL/min/1.73 m2 | |
| Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint | Placebo | -2.7 | Standard Deviation 1.19 | mL/min/1.73 m2 |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD1722 | 77 | |
| Overall Study | STARTED | Placebo | 77 | |
| Overall Study | COMPLETED | AZD1722 | 51 | |
| Overall Study | COMPLETED | Placebo | 66 | |
| Overall Study | NOT COMPLETED | AZD1722 | 26 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
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 | AZD1722 | 45 | 77 | 45 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 4 | 77 | 4 |
| serious | Hyperkalemia | Investigations | AZD1722 | 2 | 77 | 2 |
| serious | Hyperkalemia | Investigations | Placebo | 1 | 77 | 1 |
| serious | Deep Vein Thrombosis | Blood and lymphatic system disorders | AZD1722 | 1 | 77 | 1 |
| serious | Deep Vein Thrombosis | Blood and lymphatic system disorders | Placebo | 0 | 77 | 0 |
| serious | Cardiac failure congestive | Cardiac disorders | AZD1722 | 0 | 77 | 0 |
| serious | Cardiac failure congestive | Cardiac disorders | Placebo | 1 | 77 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD1722 | 0 | 77 |
| Total, all-cause mortality | Placebo | 0 | 77 |
| Total, other adverse events | AZD1722 | 45 | 77 |
| Total, other adverse events | Placebo | 4 | 77 |
| Total, serious adverse events | AZD1722 | 3 | 77 |
| Total, serious adverse events | Placebo | 2 | 77 |
Source ClinicalTrials.gov
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.
| Comparison | Source |
|---|---|
| AZD1722 vs Placebo: deaths from any cause | Trial comparisons |
| AZD1722 vs Placebo: serious adverse events | Trial 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.
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