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Clinical Trial Details

Trial ID: L1598
Source ID: NCT02675998
Associated Drug: Tenapanor
Title: An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02675998/results
Conditions: Hyperphosphatemia
Interventions: DRUG: Tenapanor|DRUG: Placebo
Outcome Measures: Primary: Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor Arms, Serum phosphorus difference between placebo and tenapanor in the change from the end of the 8 week treatment period to the end of the randomized withdrawal period in Efficacy Analysis Set. The efficacy analysis was pre-defined to be a pooled analysis of all tenapanor treated patients with a minimum of a 1.2 mg/dL decrease in serum phosphorus during the 8-week treatment period, 4 weeks | Secondary: Change in Serum Phosphate During 8-Week Treatment Period, Serum phosphorus difference between baseline (end of washout period) to the end of the 8 week treatment period in ITT analysis set, Baseline and 8 weeks
Sponsor/Collaborators: Sponsor: Ardelyx
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 219
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-01
Completion Date: 2018-01-17
Results First Posted: 2020-08-10
Last Update Posted: 2020-08-10
Locations: Ardelyx Investigative Site 429, Huntsville, Alabama, 35805, United States|Ardelyx Investigative Site 425, Riverside, California, 92505, United States|Ardelyx Clinical Site 403, Denver, Colorado, 80230, United States|Ardelyx Investigative Site 410, Lauderdale Lakes, Florida, 33313, United States|Ardelyx Investigative Site 430, Miami, Florida, 33173, United States|Ardelyx Investigative Site 427, Meridian, Idaho, 83642, United States|Ardelyx Investigative Site 432, Shreveport, Louisiana, 71101, United States|Ardelyx Investigative Site 415, Bethesda, Maryland, 20814, United States|Ardelyx Investigative Site 402, Kalamazoo, Michigan, 49008, United States|Ardelyx Investigative Site 424, Roseville, Michigan, 48066, United States|Ardelyx Investigative Site 409, Brookhaven, Mississippi, 39601, United States|Ardelyx Investigative Site 417, Columbus, Mississippi, 39705, United States|Ardelyx Investigative Site 431, Tupelo, Mississippi, 38801, United States|Ardelyx Investigative Site 423, Saint Louis, Missouri, 63136, United States|Ardelyx Investigative Site 416, Albuquerque, New Mexico, 87109, United States|Ardelyx Investigative Site 419, Bronx, New York, 10803, United States|Ardelyx Investigative Site 408, Asheville, North Carolina, 28805, United States|Ardelyx Investigative Site 411, Charlotte, North Carolina, 28204, United States|Ardelyx Investigative Site 420, New Bern, North Carolina, 28562, United States|Ardelyx Investigative Site 426, Raleigh, North Carolina, 27609, United States|Ardelyx Investigative Site 412, Wilmington, North Carolina, 28403, United States|Ardelyx Investigative Site 414, Bethlehem, Pennsylvania, 18017, United States|Ardelyx Investigative Site 404, Columbia, South Carolina, 29203, United States|Ardelyx Investigative Site 421, Orangeburg, South Carolina, 29118, United States|Ardelyx Investigative Site 428, Sumter, South Carolina, 29150, United States|Ardelyx Investigative Site 413, Knoxville, Tennessee, 37923, United States|Ardelyx Investigative Site 418, Nashville, Tennessee, 37205, United States|Ardelyx Investigative Site 406, Austin, Texas, 78758, United States|Ardelyx Investigative Site 405, Bellville, Texas, 77418, United States|Ardelyx Investigative Site 422, San Antonio, Texas, 78215, United States|Ardelyx Investigative Site 407, San Antonio, Texas, 78229, United States|Ardelyx Investigative Site 401, Saint George, Utah, 84790, United States
URL: https://clinicaltrials.gov/show/NCT02675998

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress