Ignite Creation Date:
2024-05-06 @ 1:17 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03988920
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2019-06-14
Brief Title:
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
Sponsor:
Ardelyx
Organization:
Ardelyx
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NORMALIZE
Brief Summary:
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 25 and 45 mgdL in patients with end-stage renal disease ESRD on dialysis with hyperphosphatemia 45 mgdL
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None