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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperphosphatemia

In brief

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.

Key facts

Study ID

NCT02675998

Run by

Ardelyx

People needed

219

Starts

2016-01-01

Expected to finish

2018-01-17

Last updated by the study team

2020-08-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ardelyx Investigative Site 429 — Huntsville, Alabama, United States
• Ardelyx Investigative Site 425 — Riverside, California, United States
• Ardelyx Clinical Site 403 — Denver, Colorado, United States
• Ardelyx Investigative Site 410 — Lauderdale Lakes, Florida, United States
• Ardelyx Investigative Site 430 — Miami, Florida, United States
• Ardelyx Investigative Site 427 — Meridian, Idaho, United States
• Ardelyx Investigative Site 432 — Shreveport, Louisiana, United States
• Ardelyx Investigative Site 415 — Bethesda, Maryland, United States
• Ardelyx Investigative Site 402 — Kalamazoo, Michigan, United States
• Ardelyx Investigative Site 424 — Roseville, Michigan, United States
• Ardelyx Investigative Site 409 — Brookhaven, Mississippi, United States
• Ardelyx Investigative Site 417 — Columbus, Mississippi, United States
• Ardelyx Investigative Site 431 — Tupelo, Mississippi, United States
• Ardelyx Investigative Site 423 — St Louis, Missouri, United States
• Ardelyx Investigative Site 416 — Albuquerque, New Mexico, United States
• Ardelyx Investigative Site 419 — The Bronx, New York, United States
• Ardelyx Investigative Site 408 — Asheville, North Carolina, United States
• Ardelyx Investigative Site 411 — Charlotte, North Carolina, United States
• Ardelyx Investigative Site 420 — New Bern, North Carolina, United States
• Ardelyx Investigative Site 426 — Raleigh, North Carolina, United States
• Ardelyx Investigative Site 412 — Wilmington, North Carolina, United States
• Ardelyx Investigative Site 414 — Bethlehem, Pennsylvania, United States
• Ardelyx Investigative Site 404 — Columbia, South Carolina, United States
• Ardelyx Investigative Site 421 — Orangeburg, South Carolina, United States
• Ardelyx Investigative Site 428 — Sumter, South Carolina, United States

Full record on ClinicalTrials.gov

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