Back to resultsA Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP (NORMALIZE)
Primary Purpose
Hyperphosphatemia, End Stage Renal Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tenapanor
Sevelamer Carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia
Eligibility Criteria
Inclusion Criteria:
- Must complete TEN-02-301 (PHREEDOM)
Exclusion Criteria:
- Schedlued for kidney transplant
- Life expectancy <12 months
Sites / Locations
- Ardelyx Site #509
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Tenapanor w/Sevelamer
Sevelamer w/Tenapanor
Arm Description
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
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
Outcomes
Primary Outcome Measures
Achieving Normal Serum Phosphorus Level
Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03988920
Brief Title
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
Acronym
NORMALIZE
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
June 26, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardelyx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 >2.5 and ≤4.5 mg/dL) in patients with end-stage renal disease (ESRD) on dialysis with hyperphosphatemia (>4.5 mg/dL).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tenapanor w/Sevelamer
Arm Type
Experimental
Arm Description
Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
Arm Title
Sevelamer w/Tenapanor
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tenapanor
Intervention Description
NHE3 Inhibitor
Intervention Type
Drug
Intervention Name(s)
Sevelamer Carbonate
Intervention Description
Phosphate binder
Primary Outcome Measure Information:
Title
Achieving Normal Serum Phosphorus Level
Description
Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline
Description
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
Time Frame
up to 2.5 years
Title
Change From Baseline in Serum Phosphorus (of Extension Study; TEN-02-401) to Endpoint Visit
Description
Baseline upon enrollment in the 18-month long-term extension study
Time Frame
up to 18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must complete TEN-02-301 (PHREEDOM)
Exclusion Criteria:
Schedlued for kidney transplant
Life expectancy <12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P Rosenbaum, PhD
Organizational Affiliation
Ardelyx
Official's Role
Study Director
Facility Information:
Facility Name
Ardelyx Site #509
City
Houston
State/Province
California
ZIP/Postal Code
77099
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
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