Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

• Status: Completed
• Trial end date: 2019-07-17
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardelyx
• Treatments: Calcium; Calcium acetate; Calcium Carbonate; Calcium, Dietary; Sevelamer

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 (IBS-D).

• 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 uninterpretable.