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

Ardelyx

Status and phase: Completed; Phase 4

Conditions: End Stage Renal Disease; Hyperphosphatemia

Treatments: Drug: Sevelamer Carbonate; Drug: Tenapanor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03988920

TEN-02-401

Details and patient eligibility

About

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).

Full 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.

Enrollment: 172 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must complete TEN-02-301 (PHREEDOM)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Tenapanor w/Sevelamer

Experimental group

Description:

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

Treatment:

Drug: Sevelamer Carbonate

Drug: Tenapanor

Sevelamer w/Tenapanor

Experimental group

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

Treatment:

Drug: Sevelamer Carbonate

Drug: Tenapanor