Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy
Trial end date:
SummaryThis 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.
Phase:Phase 2/Phase 3
Accepts Healthy Volunteers?No
- Signed and dated informed consent prior to any study specific procedures.
- Males or females aged 18 to 80 years, inclusive, at Screening
- Females must be non-pregnant, non-lactating and either be post-menopausal for at least
-2 months, have documentation of irreversible surgical sterilization, use of
acceptable -contraceptive method, or sexual abstinence, or a sterile sexual partner
from Screening -until 30 days after the last subject visit.
- Males must agree to avoid fathering a child (or donating sperm), and therefore be
either sterile (documented) or agree to use approved methods of contraception, from
the time of enrollment until 30 days after end of study.
- Chronic maintenance hemodialysis (HD) 3x/week for at least 3 months or chronic
maintenance peritoneal dialysis (PD) for a minimum of 6 months.
- If receiving active vitamin D or calcimimetics, the dose should have been unchanged
for the last 4 weeks prior to Screening.
- Kt/V ≥1.2 at most recent measurement prior to Screening.
- Prescribed and taking phosphate binder medication at least 3 times per day, and the
prescribed dose should have been unchanged during the last 4 weeks prior to Screening.
- Serum phosphorus levels must be ≥5.5 and ≤10.0 mg/dL at Screening and the end of the
run-in period, analyzed at the central laboratory used in the study.
- Severe hyperphosphatemia defined as having an s-P level >10.0 mg/dL on
phosphate-binders at any time point during routine clinical monitoring for the 3
preceding months before Screening.
- Serum/plasma parathyroid hormone >1200 pg/mL.
- Clinical signs of hypovolemia at Screening as judged by the Investigator.
- History of inflammatory bowel disease (IBD) or irritable bowel syndrome with diarrhea
- Scheduled for living donor kidney transplant or plans to relocate to another center
during the study period.
- Use of an investigational agent within 30 days prior to Screening.
- Involvement in the planning and/or conduct of the study (applies to both
Ardelyx/Contract Research Organization (CRO) staff and/or staff at the study site).
- If, in the opinion of the Investigator, the subject is unable or unwilling to fulfill
the requirements of the protocol or has a condition which would render the results