A Long-Term Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)
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|ClinicalTrials.gov Identifier: NCT03988920|
Recruitment Status : Active, not recruiting
First Posted : June 18, 2019
Last Update Posted : April 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hyperphosphatemia End Stage Renal Disease||Drug: Tenapanor Drug: Sevelamer Carbonate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)|
|Actual Study Start Date :||June 15, 2019|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||March 2021|
Experimental: Tenapanor w/Sevelamer
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Drug: Sevelamer Carbonate
Experimental: 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
Drug: Sevelamer Carbonate
- Achieving normal serum phosphorus level [ Time Frame: 18 months ]Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988920
|United States, California|
|Ardelyx Site #509|
|Houston, California, United States, 77099|