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

Part of paid clinical trials in Houston, California.

Sponsor
Ardelyx
Study ID
NCT03988920
Phase
PHASE4
Status
Completed

Conditions

  • End Stage Renal Disease
  • Hyperphosphatemia

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tenapanor — DRUG
    NHE3 Inhibitor
  • Sevelamer Carbonate — DRUG
    Phosphate binder

Study Details

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).

Key Dates

Start date
Jun 15, 2019
Status verified
Mar 2023
Primary completion
Jun 26, 2021
Completion
Jul 31, 2021

Study Design

Enrollment
172 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tenapanor w/Sevelamer
    Tenapanor will be administered QD or BID and sevelamer can be added to achieve desired serum phosphorus level
  • 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

Primary Outcome Measure

Achieving Normal Serum Phosphorus Level [ Time Frame: 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ardelyx Site #509HoustonCalifornia77099-

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By research site
Ardelyx· Houston, CA

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