Trial Outcomes & Findings for A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria (NCT NCT01847092)
NCT ID: NCT01847092
Last Updated: 2020-05-27
Results Overview
The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
Week 12
Results posted on
2020-05-27
Participant Flow
Participant milestones
| Measure |
AZD1722
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
AZD1722
|
Placebo
Placebo capsule BID PO for 12 Weeks
Placebo: Placebo for AZD1722
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
77
|
|
Overall Study
COMPLETED
|
51
|
66
|
|
Overall Study
NOT COMPLETED
|
26
|
11
|
Reasons for withdrawal
| Measure |
AZD1722
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
AZD1722
|
Placebo
Placebo capsule BID PO for 12 Weeks
Placebo: Placebo for AZD1722
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Protocol Specified
|
8
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
Baseline characteristics by cohort
| Measure |
AZD1722
n=77 Participants
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
AZD1722
|
Placebo
n=77 Participants
Placebo capsule BID PO for 12 Weeks
Placebo: Placebo for AZD1722
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 8.79 • n=99 Participants
|
65.6 years
STANDARD_DEVIATION 8.77 • n=107 Participants
|
65.1 years
STANDARD_DEVIATION 8.77 • n=206 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 12The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment
Outcome measures
| Measure |
AZD1722
n=77 Participants
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
AZD1722
|
Placebo
n=77 Participants
Placebo capsule BID PO for 12 Weeks
Placebo: Placebo for AZD1722
|
|---|---|---|
|
Changes in Urine Albumin to Creatinine Ratio (UACR)
|
-64.6 mg/g
Standard Deviation 898.4
|
104.8 mg/g
Standard Deviation 668.0
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
AZD1722
n=77 Participants
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
AZD1722
|
Placebo
n=77 Participants
Placebo capsule BID PO for 12 Weeks
Placebo: Placebo for 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
|
-2.7 mL/min/1.73 m2
Standard Deviation 1.19
|
Adverse Events
AZD1722
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD1722
n=77 participants at risk
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
AZD1722
|
Placebo
n=77 participants at risk
Placebo capsule BID PO for 12 Weeks
Placebo: Placebo for AZD1722
|
|---|---|---|
|
Investigations
Hyperkalemia
|
2.6%
2/77 • Number of events 2 • 12 Weeks
|
1.3%
1/77 • Number of events 1 • 12 Weeks
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
1.3%
1/77 • Number of events 1 • 12 Weeks
|
0.00%
0/77 • 12 Weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/77 • 12 Weeks
|
1.3%
1/77 • Number of events 1 • 12 Weeks
|
Other adverse events
| Measure |
AZD1722
n=77 participants at risk
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
AZD1722
|
Placebo
n=77 participants at risk
Placebo capsule BID PO for 12 Weeks
Placebo: Placebo for AZD1722
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
58.4%
45/77 • Number of events 45 • 12 Weeks
|
5.2%
4/77 • Number of events 4 • 12 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60