Clinical Trial: An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An 8-week, Multicenter, Randomized, Double-Blind, Parallel Group Study With a 4-week, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Efficacy, Safety, and Tolerability of Tenapanor t
Brief 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.
Detailed Summary:
The study consists of a screening visit, a wash out period of up to 3 weeks, when existing phosphate lowering medication is withheld, an 8-week treatment period, in which all groups receive tenapanor, and a 4-week placebo-controlled, randomized withdrawal period, during which patients are re-randomized 1:1 to either remain on their current tenapanor treatment or placebo.
Depending on the increase in serum phosphate levels, subjects can be randomized 1,2, or 3 weeks after being taken off their phosphate lowering medication.
Sponsor: Ardelyx
Current Primary Outcome: Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period [ Time Frame: 4 weeks ]
Original Primary Outcome: Change in Serum Phosphate from Baseline [ Time Frame: 8 weeks ]
Current Secondary Outcome: Change in Serum Phosphate from Baseline [ Time Frame: 8 weeks ]
Original Secondary Outcome:
- Change in Serum Phosphate during Randomized Withdrawal Period [ Time Frame: 4 weeks ]
- Change in Serum Phosphate [ Time Frame: 12 weeks ]
Information By: Ardelyx
Dates:
Date Received: February 3, 2016
Date Started: January 2016
Date Completion:
Last Updated: January 29, 2017
Last Verified: January 2017