Trial Outcomes & Findings for Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia (NCT NCT04549597)
NCT ID: NCT04549597
Last Updated: 2023-03-29
Results Overview
To evaluate the effect of tenapanor alone or in combination with phosphate binders to achieve target serum phosphorus (s-P) levels of ≤5.5 mg/dL when tenapanor is administered as the core therapy for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
333 participants
Primary outcome timeframe
10 weeks
Results posted on
2023-03-29
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Straight Switch)
Patients stop taking phosphate binder and are immediately started on tenapanor 30 mg twice daily (BID)
|
Cohort 2 (50% Phosphate Binder Reduction)
Phosphate binder dose is decreased by at least 50% and tenapanor is initiated
|
Cohort 3: Phosphate Binder Naive
Phosphate binder naive patients are enrolled as Cohort 3 and receive tenapanor with a starting dose of 30 mg/BID
Tenapanor: Use of tenapanor
|
|---|---|---|---|
|
Overall Study
STARTED
|
151
|
152
|
30
|
|
Overall Study
COMPLETED
|
127
|
133
|
25
|
|
Overall Study
NOT COMPLETED
|
24
|
19
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia
Baseline characteristics by cohort
| Measure |
Cohort 1
n=151 Participants
Phosphate binders are stopped and tenapanor is started immediately upon enrollment
|
Cohort 2
n=152 Participants
Phosphate binder dose is decreased by at least 50% and tenapanor is initiated
|
Cohort 3: Phosphate Binder Naïve
n=30 Participants
Phosphate binder naive patients are enrolled as Cohort 3 and receive tenapanor with a starting dose of 30 mg/BID
Tenapanor: Use of tenapanor
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 11.05 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 12.16 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 16.52 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 12.13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
109 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
240 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
66 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
146 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 10 weeksTo evaluate the effect of tenapanor alone or in combination with phosphate binders to achieve target serum phosphorus (s-P) levels of ≤5.5 mg/dL when tenapanor is administered as the core therapy for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
Outcome measures
| Measure |
Cohort 1: Straight Switch
n=151 Participants
Patients stop taking phosphate binders and start tenapanor 30 mg twice daily
Tenapanor: Use of tenapanor
|
Cohort 2: Decrease Phosphate Binder by 50%
n=152 Participants
Decreases phosphate binder dose by at least 50% with the ability to switch the binder regiment from thrice daily (TID) to BID or once a day and initiates tenapanor 30 mg BID
Tenapanor: Use of tenapanor
|
Cohort 3: Phosphate Binder Naive
n=30 Participants
Phosphate binder naive patients are enrolled as Cohort 3 and receive tenapanor with a starting dose of 30 mg/BID
Tenapanor: Use of tenapanor
|
|---|---|---|---|
|
Effect of Tenapanor to Achieve Target s-P Levels of Less Than or Equal to 5.5 mg/dL
|
52 Participants
|
58 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 10 weeksEvaluating the ability of different treatment regimens to lower s-P to different levels
Outcome measures
| Measure |
Cohort 1: Straight Switch
n=151 Participants
Patients stop taking phosphate binders and start tenapanor 30 mg twice daily
Tenapanor: Use of tenapanor
|
Cohort 2: Decrease Phosphate Binder by 50%
n=152 Participants
Decreases phosphate binder dose by at least 50% with the ability to switch the binder regiment from thrice daily (TID) to BID or once a day and initiates tenapanor 30 mg BID
Tenapanor: Use of tenapanor
|
Cohort 3: Phosphate Binder Naive
n=30 Participants
Phosphate binder naive patients are enrolled as Cohort 3 and receive tenapanor with a starting dose of 30 mg/BID
Tenapanor: Use of tenapanor
|
|---|---|---|---|
|
To Evaluate the Effect of Tenapanor to Achieve Various s-P Levels ≤4.5 mg/dL
|
18 Participants
|
23 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Cohort 3 is not included since they are medication naive so there is no baseline pill weight
Evaluating the ability of tenapanor to make the phosphate lowering treatment regimen better for patients by evaluating the change in pill weight or pill number from baseline to the end of the 10-week treatment period.
Outcome measures
| Measure |
Cohort 1: Straight Switch
n=151 Participants
Patients stop taking phosphate binders and start tenapanor 30 mg twice daily
Tenapanor: Use of tenapanor
|
Cohort 2: Decrease Phosphate Binder by 50%
n=152 Participants
Decreases phosphate binder dose by at least 50% with the ability to switch the binder regiment from thrice daily (TID) to BID or once a day and initiates tenapanor 30 mg BID
Tenapanor: Use of tenapanor
|
Cohort 3: Phosphate Binder Naive
Phosphate binder naive patients are enrolled as Cohort 3 and receive tenapanor with a starting dose of 30 mg/BID
Tenapanor: Use of tenapanor
|
|---|---|---|---|
|
To Evaluate the Effect of Tenapanor on Reducing Daily Phosphorus-lowering Therapy Pill Burden.
|
-6262 mg
Standard Deviation 6149.7
|
-3290 mg
Standard Deviation 5263.4
|
—
|
Adverse Events
Cohort 1
Serious events: 20 serious events
Other events: 59 other events
Deaths: 1 deaths
Cohort 2
Serious events: 26 serious events
Other events: 64 other events
Deaths: 1 deaths
Cohort 3: Phosphate Binder Naïve
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=151 participants at risk
Switch medication from phosphate binder to tenapanor upon enrollment
Tenapanor: Use of tenapanor
|
Cohort 2
n=152 participants at risk
Phosphate binder is decreased by at least 50% upon enrollment and tenapanor is added
Tenapanor: Use of tenapanor
|
Cohort 3: Phosphate Binder Naïve
n=30 participants at risk
Phosphate binder naive patients are enrolled as Cohort 3 and receive tenapanor with a starting dose of 30 mg/BID
Tenapanor: Use of tenapanor
|
|---|---|---|---|
|
Infections and infestations
Covid-19
|
1.3%
2/151 • Number of events 2 • 10 week treatment period followed by optional 16 week extension period
|
3.3%
5/152 • Number of events 5 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
3/151 • Number of events 3 • 10 week treatment period followed by optional 16 week extension period
|
1.3%
2/152 • Number of events 2 • 10 week treatment period followed by optional 16 week extension period
|
3.3%
1/30 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.3%
2/151 • Number of events 2 • 10 week treatment period followed by optional 16 week extension period
|
2.6%
4/152 • Number of events 4 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.0%
3/151 • Number of events 3 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/152 • 10 week treatment period followed by optional 16 week extension period
|
3.3%
1/30 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
|
Cardiac disorders
Fluid Overload
|
0.66%
1/151 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
1.3%
2/152 • Number of events 2 • 10 week treatment period followed by optional 16 week extension period
|
3.3%
1/30 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
|
Cardiac disorders
Chest Pain
|
0.66%
1/151 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
1.3%
2/152 • Number of events 2 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Infections and infestations
Sepsis
|
1.3%
2/151 • Number of events 2 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/152 • 10 week treatment period followed by optional 16 week extension period
|
3.3%
1/30 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
|
Infections and infestations
Peritonitis
|
0.00%
0/151 • 10 week treatment period followed by optional 16 week extension period
|
2.0%
3/152 • Number of events 3 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.66%
1/151 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
0.66%
1/152 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.66%
1/151 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
0.66%
1/152 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
1.3%
2/151 • Number of events 2 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/152 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/151 • 10 week treatment period followed by optional 16 week extension period
|
1.3%
2/152 • Number of events 2 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Infections and infestations
Arteriovenous Fistula Site Infection
|
0.00%
0/151 • 10 week treatment period followed by optional 16 week extension period
|
0.66%
1/152 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Infections and infestations
Catheter Site Infection
|
0.00%
0/151 • 10 week treatment period followed by optional 16 week extension period
|
0.66%
1/152 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Infections and infestations
Influenza
|
0.00%
0/151 • 10 week treatment period followed by optional 16 week extension period
|
0.66%
1/152 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
0.00%
0/151 • 10 week treatment period followed by optional 16 week extension period
|
0.66%
1/152 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
0.66%
1/151 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/152 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.66%
1/151 • Number of events 1 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/152 • 10 week treatment period followed by optional 16 week extension period
|
0.00%
0/30 • 10 week treatment period followed by optional 16 week extension period
|
Other adverse events
| Measure |
Cohort 1
n=151 participants at risk
Switch medication from phosphate binder to tenapanor upon enrollment
Tenapanor: Use of tenapanor
|
Cohort 2
n=152 participants at risk
Phosphate binder is decreased by at least 50% upon enrollment and tenapanor is added
Tenapanor: Use of tenapanor
|
Cohort 3: Phosphate Binder Naïve
n=30 participants at risk
Phosphate binder naive patients are enrolled as Cohort 3 and receive tenapanor with a starting dose of 30 mg/BID
Tenapanor: Use of tenapanor
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
39.1%
59/151 • Number of events 59 • 10 week treatment period followed by optional 16 week extension period
|
42.1%
64/152 • Number of events 64 • 10 week treatment period followed by optional 16 week extension period
|
33.3%
10/30 • Number of events 10 • 10 week treatment period followed by optional 16 week extension period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications subject to the Sponsor's approval requirements.
- Publication restrictions are in place
Restriction type: OTHER