- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02675998
An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
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 to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35805
- Ardelyx Investigative Site 429
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California
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Riverside, California, United States, 92505
- Ardelyx Investigative Site 425
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Colorado
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Denver, Colorado, United States, 80230
- Ardelyx Clinical Site 403
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Florida
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Lauderdale Lakes, Florida, United States, 33313
- Ardelyx Investigative Site 410
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Miami, Florida, United States, 33173
- Ardelyx Investigative Site 430
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Idaho
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Meridian, Idaho, United States, 83642
- Ardelyx Investigative Site 427
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Louisiana
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Shreveport, Louisiana, United States, 71101
- Ardelyx Investigative Site 432
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Maryland
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Bethesda, Maryland, United States, 20814
- Ardelyx Investigative Site 415
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Michigan
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Kalamazoo, Michigan, United States, 49008
- Ardelyx Investigative Site 402
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Roseville, Michigan, United States, 48066
- Ardelyx Investigative Site 424
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Mississippi
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Brookhaven, Mississippi, United States, 39601
- Ardelyx Investigative Site 409
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Columbus, Mississippi, United States, 39705
- Ardelyx Investigative Site 417
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Tupelo, Mississippi, United States, 38801
- Ardelyx Investigative Site 431
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Missouri
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Saint Louis, Missouri, United States, 63136
- Ardelyx Investigative Site 423
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Ardelyx Investigative Site 416
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New York
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Bronx, New York, United States, 10803
- Ardelyx Investigative Site 419
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North Carolina
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Asheville, North Carolina, United States, 28805
- Ardelyx Investigative Site 408
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Charlotte, North Carolina, United States, 28204
- Ardelyx Investigative Site 411
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New Bern, North Carolina, United States, 28562
- Ardelyx Investigative Site 420
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Raleigh, North Carolina, United States, 27609
- Ardelyx Investigative Site 426
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Wilmington, North Carolina, United States, 28403
- Ardelyx Investigative Site 412
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18017
- Ardelyx Investigative Site 414
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South Carolina
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Columbia, South Carolina, United States, 29203
- Ardelyx Investigative Site 404
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Orangeburg, South Carolina, United States, 29118
- Ardelyx Investigative Site 421
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Sumter, South Carolina, United States, 29150
- Ardelyx Investigative Site 428
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Tennessee
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Knoxville, Tennessee, United States, 37923
- Ardelyx Investigative Site 413
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Nashville, Tennessee, United States, 37205
- Ardelyx Investigative Site 418
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Texas
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Austin, Texas, United States, 78758
- Ardelyx Investigative Site 406
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Bellville, Texas, United States, 77418
- Ardelyx Investigative Site 405
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San Antonio, Texas, United States, 78215
- Ardelyx Investigative Site 422
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San Antonio, Texas, United States, 78229
- Ardelyx Investigative Site 407
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Utah
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Saint George, Utah, United States, 84790
- Ardelyx Investigative Site 401
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Experimental: 3mg BID
Tenapanor, 3mg BID (6mg total)
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Other Names:
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Experimental: 10mg BID
Tenapanor, 10mg BID (20mg total)
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Other Names:
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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
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor Arms
Time Frame: 4 weeks
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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
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Serum Phosphate During 8-Week Treatment Period
Time Frame: Baseline and 8 weeks
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Serum phosphorus difference between baseline (end of washout period) to the end of the 8 week treatment period in ITT analysis set
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Baseline and 8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEN-02-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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