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Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia

NCT04549597 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2023-03-29

Study results available
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Summary

This is a randomized, open-label study to evaluate different methods of initiating tenapanor therapy in CKD patients on dialysis with hyperphosphatemia, when they are either phosphate binder naïve or on phosphate binder therapy. The objective to evaluate the effect of tenapanor alone or in combination with phosphate binders to achieve target serum phosphorus (s-P) levels of ≤5.5 mg/dL when tenapanor is administered as the core therapy (alone or in combination with phosphate binders) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

Conditions

  • Chronic Kidney Disease Requiring Chronic Dialysis
  • Hyperphosphatemia

Interventions

DRUG

Tenapanor

Use of tenapanor

Sponsors & Collaborators

  • Ardelyx

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2021-10-13
Completion
2021-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04549597 on ClinicalTrials.gov