A Phase 2 interventional study of AZD1722 and Placebo in Chronic Kidney Disease and Type 2 Diabetes Mellitus, sponsored by Ardelyx. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-27.
Sponsored by Ardelyx · Phase 2, Interventional, and Treatment
The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 154 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Ardelyx is the lead sponsor of 28 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
Drug: AZD1722
Placebo capsule BID PO for 12 Weeks
Drug: Placebo
Placebo for AZD1722
Changes in Urine Albumin to Creatinine Ratio (UACR)
The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment
Time frame: Week 12
Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint
Time frame: 12 weeks
| Milestone | AZD1722 | Placebo |
|---|---|---|
| Started | 77 | 77 |
| Completed | 51 | 66 |
| Not completed | 26 | 11 |
| Withdrew: Adverse event | 12 | 3 |
| Withdrew: Withdrawal by subject | 5 | 5 |
| Withdrew: Protocol specified | 8 | 0 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Protocol violation | 0 | 2 |
The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment
| mg/g | AZD1722 | Placebo |
|---|---|---|
| Changes in Urine Albumin to Creatinine Ratio (UACR) | -64.6 ± 898.4 | 104.8 ± 668.0 |
| mL/min/1.73 m2 | AZD1722 | Placebo |
|---|---|---|
| Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint | -2.8 ± 1.21 | -2.7 ± 1.19 |
Collected over 12 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AZD1722 | 0/77 (0%) | 3/77 (3.9%) | 45/77 (58.4%) |
| Placebo | 0/77 (0%) | 2/77 (2.6%) | 4/77 (5.2%) |
| Event | AZD1722 | Placebo |
|---|---|---|
| HyperkalemiaInvestigations | 2/77 | 1/77 |
| Deep Vein ThrombosisBlood and lymphatic system disorders | 1/77 | 0/77 |
| Cardiac failure congestiveCardiac disorders | 0/77 | 1/77 |
| Event | AZD1722 | Placebo |
|---|---|---|
| DiarrheaGastrointestinal disorders | 45/77 | 4/77 |
| Age, Continuous(years) | AZD1722 | Placebo | Total |
|---|---|---|---|
| Mean | 64.6 ± 8.79 | 65.6 ± 8.77 | 65.1 ± 8.77 |
| Sex: Female, Male(Participants) | AZD1722 | Placebo | Total |
|---|---|---|---|
| Female | 52 | 52 | 104 |
| Male | 25 | 25 | 50 |
| Ethnicity (NIH/OMB)(Participants) | AZD1722 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 18 | 19 | 37 |
| Not Hispanic or Latino | 59 | 58 | 117 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AZD1722 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 21 | 18 | 39 |
| White | 53 | 53 | 106 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 4 | 5 |
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ardelyx