A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

Part of paid clinical trials in The Bronx, New York.

Sponsor
Ardelyx
Study ID
NCT03427125
Phase
PHASE3
Status
Completed

Conditions

  • Hyperphosphatemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tenapanor — DRUG
    Active Drug
  • Placebo — DRUG
    Inactive Drug
  • Sevelamer Carbonate — DRUG
    Active control

Study Details

This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized withdrawal period followed by an open label long term safety extension will evaluate the safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD) on hemodialysis and peritoneal dialysis.

Key Dates

Start date
Jan 8, 2018
Status verified
Jun 2023
Primary completion
Nov 15, 2019
Completion
Feb 27, 2020

Study Design

Enrollment
1,559 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tenapanor 10 mg, 20 mg, 30 mg BID
    During the 26-week open label part, all enrolled subjects will receive 30 mg BID doses of tenapanor. Investigators may decrease or increase the dose in 10 mg increments to a minimum of 10 g BIDor a maximum of 30 mg BID
  • Placebo Comparator: Placebo
    Placebo
  • Active Comparator: Sevelamer Carbonate
    Subjects randomized into the active control group, for safety analysis, will receive sevelamer carbonate, open label, for the entire 52-week study period. Sevelamer carbonate will be dosed based on package insert instructions (standard of care)

Primary Outcome Measure

Change in Serum Phosphorus Levels During Placebo Controlled Randomized Withdrawal Period in the Responder Population [ Time Frame: 12 weeks (randomized withdrawal period) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Site 529The BronxNew York10461-
Wake Forest School of MedicineWinston-SalemNorth Carolina27157-

Find similar trials in The Bronx, NY

By research site
Site 529· The Bronx, NYWake Forest School of Medicine· Winston-Salem, NC

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