An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

• Status: Completed
• Trial end date: 2018-01-17
• Target enrollment: 0
• Participant gender: All

Summary

This phase 3, 8-week, randomized, double-blind, parallel group, multi-center study with a 4-week, placebo-controlled, randomized withdrawal period will evaluate the efficacy, safety and tolerability of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients on hemodialysis (ESRD-HD). Subjects who qualify are randomized into the study will either receive 3 mg BID, 10 mg BID, or a titration regimen of tenapanor.

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

Details

• Lead Sponsor: Ardelyx

Criteria

Inclusion Criteria:

• 18 to 80 years old

• 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/week for at least 3 months

• Kt/V ≥ 1.3 at most recent measurement prior to screening

• Prescribed and taking at least 3 doses of phosphate binder per day

• Serum phosphate levels should be between 4.0 and 7.0 mg/dL (inclusive) at screening

• For randomization in the study, after 1 week wash-out of phosphate binders, subjects must have serum phosphate level of at least 9 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value

• For randomization in the study, after 2 or 3 weeks wash-out of phosphate binders, subjects must have serum phosphate level of at least 6 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value

Exclusion Criteria:

• Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening

• Serum parathyroid hormone >1200 pg/mL

• Persistent metabolic acidosis defined as serum carbon dioxide <18 mmol/L from two consecutive measurements during screening and washout periods

• Clinical signs of hypovolemia at randomization

• History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome (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

• Diarrhea or loose stools during the week before randomization defined as BSFS ≥ 6 and frequency ≥ 3 for 2 or more days

• Any evidence of or treatment of malignancy within one year, excluding non-melanomatous malignancies of the skin

• Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator

• Life expectancy < 6 months