Chronic Kidney Disease, Type 2 Diabetes Mellitus
Conditions
Keywords
albuminuria
Brief summary
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.
Interventions
DRUGAZD1722
DRUGPlacebo
Placebo for AZD1722
Sponsors
AstraZeneca
Ardelyx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males or females aged 18 to 80 years, inclusive. * Body mass index between 18 and 45 kg/m2, inclusive. * Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization * Stage 3 CKD * MSSBP ≥130 mmHg * Urinary albumin: mean UACR ≥ 200 mg/g
Exclusion criteria
* Urinary albumin: UACR \> 3500 mg/g * History of a renal transplant * MSSBP \>180 mmHg or a MSDBP of \>120 mmHg on two occasions during screening or run-in periods * History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint | 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AZD1722 AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
AZD1722 | 77 |
| Placebo Placebo capsule BID PO for 12 Weeks
Placebo: Placebo for AZD1722 | 77 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 12 | 3 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Specified | 8 | 0 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | Placebo | Total | AZD1722 |
|---|---|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 8.77 | 65.1 years STANDARD_DEVIATION 8.77 | 64.6 years STANDARD_DEVIATION 8.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 37 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 117 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 39 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) White | 53 Participants | 106 Participants | 53 Participants |
| Sex: Female, Male Female | 52 Participants | 104 Participants | 52 Participants |
| Sex: Female, Male Male | 25 Participants | 50 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 77 |
| other Total, other adverse events | 45 / 77 | 4 / 77 |
| serious Total, serious adverse events | 3 / 77 | 2 / 77 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1722 | Changes in Urine Albumin to Creatinine Ratio (UACR) | -64.6 mg/g | Standard Deviation 898.4 |
| Placebo | Changes in Urine Albumin to Creatinine Ratio (UACR) | 104.8 mg/g | Standard Deviation 668 |
p-value: 0.279Mixed Models Analysis
Secondary
Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint
Time frame: 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AZD1722 | Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint | -2.8 mL/min/1.73 m2 | Standard Deviation 1.21 |
| Placebo | Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint | -2.7 mL/min/1.73 m2 | Standard Deviation 1.19 |
p-value: 0.94ANCOVA