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

Conditions

• Hyperphosphatemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Tenapanor — DRUG
• Placebo — DRUG

Study Details

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 Dates

Start date

Jan 31, 2016

Status verified

Aug 2020

Primary completion

Dec 31, 2016

Completion

Jan 17, 2018

Study Design

Enrollment

219 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 3mg BID
  Tenapanor, 3mg BID (6mg total)
• Experimental: 10mg BID
  Tenapanor, 10mg BID (20mg total)
• Experimental: Dose Titration
  Tenapanor, patients start at 30mg BID and can down titrate weekly to 20, 15, 10, and 3mg BID, sequentially based on a GI tolerability question
• Placebo Comparator: Placebo
  Placebo

Primary Outcome Measure

Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor Arms [ Time Frame: 4 weeks ]

Locations (32)

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