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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1559 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2020-02-27

Brief Summary

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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.

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Detailed Description

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The study consists of a screening visit, a phosphate binder-free washout period of up to 4 weeks, a 26-week treatment period, an up to 12-week placebo-controlled, randomized withdrawal period, during which patients are randomized 1:1 to either remain on their tenapanor treatment or placebo, followed by an open label safety extension period for a total treatment period of up to 52 weeks. An active control group, for safety analysis only, will receive sevelamer carbonate, open label, for the entire 52-week study period

Depending on increase in serum phosphate (s-P) levels, subjects can be randomized 2 or 3 weeks after being taken off their phosphate lowering medication.

Subjects who qualify to enroll in the study will be randomized 3:1 to either receive tenapanor at a dose of 30 mg bid or sevelamer carbonate.

Conditions

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Hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Tenapanor

Intervention Type DRUG

Active Drug

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inactive Drug

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)

Group Type ACTIVE_COMPARATOR

Sevelamer Carbonate

Intervention Type DRUG

Active control

Interventions

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Tenapanor

Active Drug

Intervention Type DRUG

Placebo

Inactive Drug

Intervention Type DRUG

Sevelamer Carbonate

Active control

Intervention Type DRUG

Other Intervention Names

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RDX5791, AZD1722 Renvela

Eligibility Criteria

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Inclusion Criteria

* Females must be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods
* Males must agree to avoid fathering a child and agree to use an appropriate method of contraception
* Chronic maintenance hemodialysis 3x a week for at least 3 months
* Chronic maintenance peritoneal dialysis for a minimum of 6 months
* Kt/V ≥ 1.2 at most recent measurement prior to screening
* Prescribed and taking at least 3 doses of phosphate binder per day
* Serum phosphorus levels should be between 4.0 and 8.0 mg/dL at screening
* Unchanged dose of vitamin D or calcimimetics for the last 4 weeks prior to screening
* For enrollment in the study after at least 2 weeks of wash-out, subjects must have serum phosphorus levels of at least 6.0 mg/dL but not more than 10.0 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value after 2 or 3 weeks wash-out of phosphate binders

Exclusion Criteria

* Severe hyperphosphatemia defined as serum phosphorus greater than 10.0 mg/dL on phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening visit
* Serum/plasma parathyroid hormone \>1200 pg/mL
* Clinical signs of hypovolemia at enrollment
* History of IBD or IBS-D
* Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period
* Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator
* Life expectancy \<6 months
* Previous exposure to tenapanor

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No