Trial Outcomes & Findings for A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP (NCT NCT03988920)
NCT ID: NCT03988920
Last Updated: 2023-03-29
Results Overview
Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
172 participants
Primary outcome timeframe
18 months
Results posted on
2023-03-29
Participant Flow
Participant milestones
| Measure |
Tenapanor w/Sevelamer
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
Sevelamer w/Tenapanor
Sevelamer will be administered QD, BID or TID and tenapanor will be added to achieve desired serum phosphorus level and sevelamer dose will be decreased as needed
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
61
|
|
Overall Study
COMPLETED
|
89
|
35
|
|
Overall Study
NOT COMPLETED
|
22
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
Baseline characteristics by cohort
| Measure |
Tenapanor w/Sevelamer
n=111 Participants
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
Sevelamer w/Tenapanor
n=61 Participants
Sevelamer will be administered QD, BID or TID and tenapanor will be added to achieve desired serum phosphorus level and sevelamer dose will be decreased as needed
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.97 years
STANDARD_DEVIATION 12.146 • n=99 Participants
|
58.48 years
STANDARD_DEVIATION 14.028 • n=107 Participants
|
56.85 years
STANDARD_DEVIATION 12.861 • n=206 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
121 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
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 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
|
59 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
75 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=99 Participants
|
61 participants
n=107 Participants
|
172 participants
n=206 Participants
|
|
BMI
|
31.90 kg/m^2
STANDARD_DEVIATION 7.360 • n=99 Participants
|
29.33 kg/m^2
STANDARD_DEVIATION 7.472 • n=107 Participants
|
30.98 kg/m^2
STANDARD_DEVIATION 7.480 • n=206 Participants
|
PRIMARY outcome
Timeframe: 18 monthsProportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL
Outcome measures
| Measure |
Tenapanor w/Sevelamer
n=111 Participants
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
Sevelamer w/Tenapanor
n=60 Participants
Sevelamer will be administered QD, BID or TID and tenapanor will be added to achieve desired serum phosphorus level and sevelamer dose will be decreased as needed
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
|---|---|---|
|
Achieving Normal Serum Phosphorus Level
|
36 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: up to 2.5 yearsThe change from the baseline s-P from the parent study until the endpoint visit which was up to 2.5 years after the baseline
Outcome measures
| Measure |
Tenapanor w/Sevelamer
n=111 Participants
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
Sevelamer w/Tenapanor
n=60 Participants
Sevelamer will be administered QD, BID or TID and tenapanor will be added to achieve desired serum phosphorus level and sevelamer dose will be decreased as needed
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
|---|---|---|
|
Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline
|
-2.00 mg/dL
Standard Deviation 2.248
|
-1.91 mg/dL
Standard Deviation 1.982
|
SECONDARY outcome
Timeframe: up to 18 monthsBaseline upon enrollment in the 18-month long-term extension study
Outcome measures
| Measure |
Tenapanor w/Sevelamer
n=111 Participants
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
Sevelamer w/Tenapanor
n=60 Participants
Sevelamer will be administered QD, BID or TID and tenapanor will be added to achieve desired serum phosphorus level and sevelamer dose will be decreased as needed
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
|---|---|---|
|
Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit
|
-0.47 mg/dL
Standard Deviation 2.084
|
-0.57 mg/dL
Standard Deviation 2.422
|
Adverse Events
Tenapanor w/Sevelamer
Serious events: 56 serious events
Other events: 91 other events
Deaths: 5 deaths
Sevelamer w/Tenapanor
Serious events: 22 serious events
Other events: 52 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Tenapanor w/Sevelamer
n=111 participants at risk
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
Sevelamer w/Tenapanor
n=61 participants at risk
Tenapanor will be added and sevelamer dose will be decreased immediately after enrollment to achieve desired phosphorus level.
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
|---|---|---|
|
Infections and infestations
COVID-19
|
5.4%
6/111 • 1 year, 6 months
|
1.6%
1/61 • 1 year, 6 months
|
|
Infections and infestations
COVD-19 pnuemonia
|
3.6%
4/111 • 1 year, 6 months
|
1.6%
1/61 • 1 year, 6 months
|
|
Infections and infestations
Pneumonia
|
2.7%
3/111 • 1 year, 6 months
|
1.6%
1/61 • 1 year, 6 months
|
|
Infections and infestations
Celulitis
|
1.8%
2/111 • 1 year, 6 months
|
4.9%
3/61 • 1 year, 6 months
|
|
Infections and infestations
Sepsis
|
2.7%
3/111 • 1 year, 6 months
|
3.3%
2/61 • 1 year, 6 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.7%
3/111 • 1 year, 6 months
|
3.3%
2/61 • 1 year, 6 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.8%
2/111 • 1 year, 6 months
|
3.3%
2/61 • 1 year, 6 months
|
|
Cardiac disorders
Atrial Fibrillation
|
2.7%
3/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Cardiac disorders
Coronary Artery Disease
|
1.8%
2/111 • 1 year, 6 months
|
1.6%
1/61 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Aneurysm
|
1.8%
2/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.8%
2/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.8%
2/111 • 1 year, 6 months
|
3.3%
2/61 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
2/111 • 1 year, 6 months
|
3.3%
2/61 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.90%
1/111 • 1 year, 6 months
|
1.6%
1/61 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.90%
1/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/111 • 1 year, 6 months
|
4.9%
3/61 • 1 year, 6 months
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
1.8%
2/111 • 1 year, 6 months
|
1.6%
1/61 • 1 year, 6 months
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
1.8%
2/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Vascular disorders
Hypertensive Urgency
|
1.8%
2/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Nervous system disorders
Haemorrhage Intracranial
|
1.8%
2/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Nervous system disorders
Ischaemic Stroke
|
1.8%
2/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.90%
1/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Infections and infestations
Medical Device Site Joint Infection
|
0.90%
1/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Infections and infestations
Meningitis
|
0.90%
1/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Infections and infestations
Osteomyelitis
|
0.90%
1/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Infections and infestations
Pelvic Inflammatory Disease
|
0.90%
1/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Infections and infestations
Pneumonia Bacterial
|
0.90%
1/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.90%
1/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.90%
1/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.90%
1/111 • 1 year, 6 months
|
0.00%
0/61 • 1 year, 6 months
|
Other adverse events
| Measure |
Tenapanor w/Sevelamer
n=111 participants at risk
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
Sevelamer w/Tenapanor
n=61 participants at risk
Tenapanor will be added and sevelamer dose will be decreased immediately after enrollment to achieve desired phosphorus level.
Tenapanor: NHE3 Inhibitor
Sevelamer Carbonate: Phosphate binder
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.9%
11/111 • 1 year, 6 months
|
44.3%
27/61 • 1 year, 6 months
|
|
Infections and infestations
COVID-19
|
7.2%
8/111 • 1 year, 6 months
|
6.6%
4/61 • 1 year, 6 months
|
|
Infections and infestations
Cellulitis
|
6.3%
7/111 • 1 year, 6 months
|
4.9%
3/61 • 1 year, 6 months
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
9/111 • 1 year, 6 months
|
1.6%
1/61 • 1 year, 6 months
|
|
Infections and infestations
Pneumonia
|
4.5%
5/111 • 1 year, 6 months
|
6.6%
4/61 • 1 year, 6 months
|
|
Infections and infestations
Sepsis
|
5.4%
6/111 • 1 year, 6 months
|
3.3%
2/61 • 1 year, 6 months
|
|
Gastrointestinal disorders
Nausea
|
7.2%
8/111 • 1 year, 6 months
|
3.3%
2/61 • 1 year, 6 months
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
5/111 • 1 year, 6 months
|
8.2%
5/61 • 1 year, 6 months
|
|
Gastrointestinal disorders
Constipation
|
2.7%
3/111 • 1 year, 6 months
|
6.6%
4/61 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
8.1%
9/111 • 1 year, 6 months
|
9.8%
6/61 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication
|
6.3%
7/111 • 1 year, 6 months
|
1.6%
1/61 • 1 year, 6 months
|
|
Vascular disorders
Hypertension
|
6.3%
7/111 • 1 year, 6 months
|
4.9%
3/61 • 1 year, 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.3%
7/111 • 1 year, 6 months
|
4.9%
3/61 • 1 year, 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
5/111 • 1 year, 6 months
|
6.6%
4/61 • 1 year, 6 months
|
|
Investigations
Troponin Increased
|
0.90%
1/111 • 1 year, 6 months
|
6.6%
4/61 • 1 year, 6 months
|
|
Vascular disorders
Hypotension
|
7.2%
8/111 • 1 year, 6 months
|
4.9%
3/61 • 1 year, 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.2%
8/111 • 1 year, 6 months
|
9.8%
6/61 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.4%
6/111 • 1 year, 6 months
|
1.6%
1/61 • 1 year, 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER