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NCT Number: NCT03988920

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

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).

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Key information

Conditions

Hyperphosphatemia Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ardelyx Site #509

Houston, California, 77099, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must complete TEN-02-301 (PHREEDOM)

Exclusion criteria

  • Schedlued for kidney transplant
  • Life expectancy <12 months

Treatment and study plan

Tenapanor

Drug

NHE3 Inhibitor

Sevelamer carbonate

Drug

Phosphate binder

Primary outcomes

  1. Achieving Normal Serum Phosphorus Level

    Time frame: 18 months

    Proportion of patients with serum phosphorus between 2.5 and 4.5 mg/dL

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Ardelyx

Industry

Registry information

Official study 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)

Acronym: NORMALIZE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2019
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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