A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP (NORMALIZE)

March 3, 2023 updated by: Ardelyx

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Houston, California, United States, 77099
        • Ardelyx Site #509

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must complete TEN-02-301 (PHREEDOM)

Exclusion Criteria:

  1. Schedlued for kidney transplant
  2. Life expectancy <12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achieving Normal Serum Phosphorus Level
Time Frame: 18 months
Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Phosphorus (s-P) From TEN-02-301 (Parent Study) Baseline
Time Frame: up to 2.5 years
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
Time Frame: up to 18 months
Baseline upon enrollment in the 18-month long-term extension study
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardelyx

Investigators

  • Study Director: David P Rosenbaum, PhD, Ardelyx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2019

Primary Completion (Actual)

June 26, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEN-02-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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