This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy.
The study consists of a Screening visit; a Run-in Period of at least 2 weeks and up to 4 weeks, where existing phosphate binder treatment is maintained; and a 4-week Double-Blind Treatment Period. At Screening, a subject must be on thrice daily phosphate binder therapy and have a serum phosphate (s-P) level ≥5.5 and ≤10.0 mg/dL to qualify for entering the study. s-P will be measured at each visit during the run-in period to enable the evaluation of the s-P randomization criteria. Subjects who qualify to enroll in the study will be randomized in a 1:1 ratio to receive tenapanor or placebo while continuing their existing phosphate binder treatment. During the Double-Blind Treatment Period, subjects will receive tenapanor or placebo starting at a dose of 30 mg bid
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
236
Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.
Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.
Time frame: 4 Weeks (28 days randomization period; from baseline to week 4)
s-P Response at Week 4
Achieving an s-P level \<5.5 mg/dL
Time frame: 4 Weeks (28 days randomization period)
Relative Change From Baseline in iFGF23 at Week 4
iFGF23 at Week 4/baseline iFGF23 - 1
Time frame: 4 Weeks (28 days randomization period)
Relative Change From Baseline in cFGF23 at Week 4
cFGF23 at Week 4/baseline cFGF23 - 1
Time frame: 4 Weeks (28 days randomization period)
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