Status:
COMPLETED
A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis
Lead Sponsor:
Ardelyx
Conditions:
Hyperphosphatemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 t...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2020
Estimated Enrollment :
1559 Patients enrolled
Trial Details
Trial ID
NCT03427125
Start Date
January 8 2018
End Date
February 27 2020
Last Update
June 29 2023
Active Locations (2)
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1
Site 529
The Bronx, New York, United States, 10461
2
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157