NORMALIZE: 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

Sponsor

Ardelyx (Industry)

Overall Status

Completed

CT.gov ID

NCT03988920

Collaborator

(none)

172

Enrollment

Location

Arms

25.5

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hyperphosphatemia End Stage Renal Disease	Drug: Tenapanor Drug: Sevelamer Carbonate	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

172 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Jun 15, 2019

Actual Primary Completion Date :

Jun 26, 2021

Actual Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tenapanor w/Sevelamer Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level	Drug: Tenapanor NHE3 Inhibitor Drug: Sevelamer Carbonate Phosphate binder
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: Tenapanor NHE3 Inhibitor Drug: Sevelamer Carbonate Phosphate binder

Arm

Intervention/Treatment

Experimental: Tenapanor w/Sevelamer

Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level

Drug: Tenapanor

NHE3 Inhibitor

Drug: Sevelamer Carbonate

Phosphate binder

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: Tenapanor

NHE3 Inhibitor

Drug: Sevelamer Carbonate

Phosphate binder

Outcome Measures

Primary Outcome Measures

Achieving normal serum phosphorus level [18 months]
Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must complete TEN-02-301 (PHREEDOM)

Exclusion Criteria:

Schedlued for kidney transplant
Life expectancy <12 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ardelyx Site #509	Houston	California	United States	77099

Sponsors and Collaborators

Ardelyx

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ardelyx

ClinicalTrials.gov Identifier:

NCT03988920

Other Study ID Numbers:

TEN-02-401

First Posted:

Jun 18, 2019

Last Update Posted:

Jan 10, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Kidney Failure, Chronic

Hyperphosphatemia

Sevelamer

Study Results

No Results Posted as of Jan 10, 2022