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

Part of paid clinical trials in Lauderdale Lakes, Florida.

Sponsor
Ardelyx
Study ID
NCT04549597
Phase
PHASE4
Status
Completed

Conditions

  • Chronic Kidney Disease Requiring Chronic Dialysis
  • Hyperphosphatemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 20, 2020
Status verified
Mar 2023
Primary completion
Oct 13, 2021
Completion
Dec 1, 2021

Study Design

Enrollment
333 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Straight Switch
    Patients stop taking phosphate binders and start tenapanor 30 mg twice daily
  • Experimental: Cohort 2: Decrease Phosphate Binder by 50%
    Decreases phosphate binder dose by at least 50% with the ability to switch the binder regiment from thrice daily (TID) to BID or once a day and initiates tenapanor 30 mg BID
  • Experimental: Cohort 3: Phosphate Binder Naive
    Phosphate binder naive patients are enrolled as Cohort 3 and receive tenapanor with a starting dose of 30 mg/BID

Primary Outcome Measure

Effect of Tenapanor to Achieve Target s-P Levels of Less Than or Equal to 5.5 mg/dL [ Time Frame: 10 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
South Florida Research InstituteLauderdale LakesFlorida33313-

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South Florida Research Institute· Lauderdale Lakes, FL

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