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=5 Participants	65.6 years STANDARD_DEVIATION 8.77 • n=7 Participants	65.1 years STANDARD_DEVIATION 8.77 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	52 Participants n=7 Participants	104 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=5 Participants	58 Participants n=7 Participants	117 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

The 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 weeks

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
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

Chief Development Officer

Ardelyx

Phone: 6175134929

Email: drosenbaum@ardelyx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60