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

• Status: Completed
• Trial end date: 2020-02-27
• Target enrollment: 0
• Participant gender: All

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 tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD) on hemodialysis and peritoneal dialysis.

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

Details

• Lead Sponsor: Ardelyx
• Treatments: Sevelamer

Criteria

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