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The study is designed to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus concentration (sP) within the population reference range (sP >2.5 and ≤4.5 mg/dL) in patients with end-stage renal disease (ESRD) on dialysis with hyperphosphatemia (>4.5 mg/dL).
Patients who complete the TEN-02-301 study (PHREEDOM) may be eligible to enroll into TEN-02-401 (NORMALIZE).
Patients from the TEN-02-301 tenapanor arm will either receive only tenapanor or be given sevelamer in addition to tenapanor based on their sP. Patients from the TEN-02-301 sevelamer arm will be given tenapanor in addition to their sevelamer dose and the sevelamer dose will then be adjusted based on their sP following a protocol-specified dose titration schedule. Patients will be monitored for safety and efficacy with in-office and telephone visits for up to an additional 18 months.
Laboratory assessments will be measured at every visit (Weeks 1, 2, 3, 4, 6 and 8 and Months 3, 6, 9, 12, 15 and 18) using a central laboratory.
Safety assessments will be performed during the study and will include physical examinations, vital signs (blood pressure and pulse), body weights, clinical laboratory evaluations, 12-lead electrocardiograms (ECGs), and adverse event (AE) monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenapanor w/Sevelamer | Experimental | Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level |
|
| Sevelamer w/Tenapanor | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenapanor | Drug | NHE3 Inhibitor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Achieving Normal Serum Phosphorus Level | Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline | The change from the baseline s-P from the parent study until the endpoint visit which was up to 2.5 years after the baseline | up to 2.5 years |
| Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David P Rosenbaum, PhD | Ardelyx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ardelyx Site #509 | Houston | California | 77099 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38323855 | Derived | Sprague SM, Weiner DE, Tietjen DP, Pergola PE, Fishbane S, Block GA, Silva AL, Fadem SZ, Lynn RI, Fadda G, Pagliaro L, Zhao S, Edelstein S, Spiegel DM, Rosenbaum DP. Tenapanor as Therapy for Hyperphosphatemia in Maintenance Dialysis Patients: Results from the OPTIMIZE Study. Kidney360. 2024 May 1;5(5):732-742. doi: 10.34067/KID.0000000000000387. Epub 2024 Feb 7. | |
| 37853560 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Sevelamer w/Tenapanor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Achieving Normal Serum Phosphorus Level | Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL | Posted | Count of Participants | Participants | 18 months |
|
1 year, 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Development Officer | Ardelyx | 6175134929 | drosenbaum@ardelyx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2019 | Jan 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051436 | Renal Insufficiency, Chronic |
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| ID | Term |
|---|---|
| C000599417 | tenapanor |
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Sevelamer Carbonate |
| Drug |
Phosphate binder |
|
Baseline upon enrollment in the 18-month long-term extension study |
| up to 18 months |
| Silva AL, Chertow GM, Hernandez GT, Lynn RI, Tietjen DP, Rosenbaum DP, Yang Y, Edelstein S. Tenapanor Improves Long-Term Control of Hyperphosphatemia in Patients Receiving Maintenance Dialysis: the NORMALIZE Study. Kidney360. 2023 Nov 1;4(11):1580-1589. doi: 10.34067/KID.0000000000000280. Epub 2023 Oct 19. |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| Secondary | Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline | The change from the baseline s-P from the parent study until the endpoint visit which was up to 2.5 years after the baseline | Posted | Mean | Standard Deviation | mg/dL | up to 2.5 years |
|
|
|
| Secondary | Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit | Baseline upon enrollment in the 18-month long-term extension study | Posted | Mean | Standard Deviation | mg/dL | up to 18 months |
|
|
|
| 5 |
| 111 |
| 56 |
| 111 |
| 91 |
| 111 |
| EG001 | Sevelamer w/Tenapanor | 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 | 4 | 61 | 22 | 61 | 52 | 61 |
| COVD-19 pnuemonia | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Celulitis | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | Non-systematic Assessment |
|
| Arteriovenous Fistula Aneurysm | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Blood Loss Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Diabetic Foot | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypertensive Urgency | Vascular disorders | Non-systematic Assessment |
|
| Haemorrhage Intracranial | Nervous system disorders | Non-systematic Assessment |
|
| Ischaemic Stroke | Nervous system disorders | Non-systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Medical Device Site Joint Infection | Infections and infestations | Non-systematic Assessment |
|
| Meningitis | Infections and infestations | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | Non-systematic Assessment |
|
| Pelvic Inflammatory Disease | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia Bacterial | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia Staphylococcal | Infections and infestations | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Cardiac Failure Acute | Cardiac disorders | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Arteriovenous Fistula Site Complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Troponin Increased | Investigations | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |