Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy
- Conditions
- Hyperphosphatemia
- Interventions
- Registration Number
- NCT03824587
- Lead Sponsor
- Ardelyx
- Brief Summary
This is a randomized, double-blind, placebo-controlled study to evaluate the effect of tenapanor on change in s-P levels when tenapanor is administered orally, twice daily for 28 days as adjunctive therapy to ESRD subjects with hyperphosphatemia on stable phosphate binder therapy.
- Detailed Description
The study consists of a Screening visit; a Run-in Period of at least 2 weeks and up to 4 weeks, where existing phosphate binder treatment is maintained; and a 4-week Double-Blind Treatment Period.
At Screening, a subject must be on thrice daily phosphate binder therapy and have a serum phosphate (s-P) level ≥5.5 and ≤10.0 mg/dL to qualify for entering the study. s-P will be measured at each visit during the run-in period to enable the evaluation of the s-P randomization criteria.
Subjects who qualify to enroll in the study will be randomized in a 1:1 ratio to receive tenapanor or placebo while continuing their existing phosphate binder treatment.
During the Double-Blind Treatment Period, subjects will receive tenapanor or placebo starting at a dose of 30 mg bid
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
- Signed and dated informed consent prior to any study specific procedures.
- Males or females aged 18 to 80 years, inclusive, at Screening
- Females must be non-pregnant, non-lactating and either be post-menopausal for at least -2 months, have documentation of irreversible surgical sterilization, use of acceptable -contraceptive method, or sexual abstinence, or a sterile sexual partner from Screening -until 30 days after the last subject visit.
- Males must agree to avoid fathering a child (or donating sperm), and therefore be either sterile (documented) or agree to use approved methods of contraception, from the time of enrollment until 30 days after end of study.
- Chronic maintenance hemodialysis (HD) 3x/week for at least 3 months or chronic maintenance peritoneal dialysis (PD) for a minimum of 6 months.
- If receiving active vitamin D or calcimimetics, the dose should have been unchanged for the last 4 weeks prior to Screening.
- Kt/V ≥1.2 at most recent measurement prior to Screening.
- Prescribed and taking phosphate binder medication at least 3 times per day, and the prescribed dose should have been unchanged during the last 4 weeks prior to Screening.
- Serum phosphorus levels must be ≥5.5 and ≤10.0 mg/dL at Screening and the end of the run-in period, analyzed at the central laboratory used in the study.
- Severe hyperphosphatemia defined as having an s-P level >10.0 mg/dL on phosphate-binders at any time point during routine clinical monitoring for the 3 preceding months before Screening.
- Serum/plasma parathyroid hormone >1200 pg/mL.
- Clinical signs of hypovolemia at Screening as judged by the Investigator.
- History of inflammatory bowel disease (IBD) or irritable bowel syndrome with diarrhea (IBS-D).
- Scheduled for living donor kidney transplant or plans to relocate to another center during the study period.
- Use of an investigational agent within 30 days prior to Screening.
- Involvement in the planning and/or conduct of the study (applies to both Ardelyx/Contract Research Organization (CRO) staff and/or staff at the study site).
- If, in the opinion of the Investigator, the subject is unable or unwilling to fulfill the requirements of the protocol or has a condition which would render the results uninterpretable.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tenapanor 30 mg BID Phosphate Binder Agents During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time). Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period. Placebo Placebo same size, weight and appearance of experimental drug Placebo Phosphate Binder Agents same size, weight and appearance of experimental drug Tenapanor 30 mg BID Tenapanor During the Double-Blind Treatment Period, subjects will receive tenapanor starting at a dose of 30 mg bid (three 10 mg tablets each time). Investigators may decrease or increase the dose of study medication based on s-P levels and/or gastrointestinal (GI) tolerability in 10 mg increments to a minimum of 10 mg bid or a maximum of 30 mg bid at any time during the Double-Blind Treatment Period.
- Primary Outcome Measures
Name Time Method Change in Serum Phosphorus (s-P) Level From Baseline to Week 4. 4 Weeks (28 days randomization period; from baseline to week 4) Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.
- Secondary Outcome Measures
Name Time Method Relative Change From Baseline in cFGF23 at Week 4 4 Weeks (28 days randomization period) cFGF23 at Week 4/baseline cFGF23 - 1
s-P Response at Week 4 4 Weeks (28 days randomization period) Achieving an s-P level \<5.5 mg/dL
Relative Change From Baseline in iFGF23 at Week 4 4 Weeks (28 days randomization period) iFGF23 at Week 4/baseline iFGF23 - 1
Trial Locations
- Locations (48)
Nephrology Consultants, LLC
🇺🇸Huntsville, Alabama, United States
Mountain Kidney & Hypertension Associates, P.A.
🇺🇸Asheville, North Carolina, United States
California Institute of Renal Research - Chula Vista
🇺🇸Chula Vista, California, United States
Chabot Nephrology Medical Group
🇺🇸Union City, California, United States
North America Research Institute
🇺🇸Lynwood, California, United States
Central Coast Nephrology
🇺🇸Salinas, California, United States
US Renal Care - Waxahachie
🇺🇸Mansfield, Texas, United States
Northwell Health
🇺🇸Great Neck, New York, United States
North America Research Institute - San Dimas
🇺🇸San Dimas, California, United States
Nova Clinical Research, LLC
🇺🇸Bradenton, Florida, United States
Southeast Renal Research
🇺🇸Beverly Hills, California, United States
Dialysis Clinic, Inc - Albany GA
🇺🇸Albany, Georgia, United States
Northeast Clinical Research Center
🇺🇸Bethlehem, Pennsylvania, United States
US Renal Care - Mesquite
🇺🇸Mesquite, Texas, United States
Dialysis Clinic, Inc - Boston/Somerville
🇺🇸Boston, Massachusetts, United States
Med Center Dialysis
🇺🇸Houston, Texas, United States
University of Cincinnati (UC) - Department of Nephrology
🇺🇸Cincinnati, Ohio, United States
Total Research Group, LLC
🇺🇸Miami, Florida, United States
InterMed Consultants
🇺🇸Minneapolis, Minnesota, United States
Clinical Advancement Center, PLLC
🇺🇸San Antonio, Texas, United States
Durham Nephrology Associates
🇺🇸Durham, North Carolina, United States
US Renal Care - Pleasanton Road
🇺🇸San Antonio, Texas, United States
Nephrology and Hypertension Associates, LTD
🇺🇸Tupelo, Mississippi, United States
Kidney Specialists of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Knoxville Kidney Center, PLLC
🇺🇸Knoxville, Tennessee, United States
Sierra Nevada Nephrology Consultants
🇺🇸Reno, Nevada, United States
US Renal Care Pine Bluff
🇺🇸Pine Bluff, Arkansas, United States
Dialysis Clinic, Inc - North Brunswick
🇺🇸North Brunswick, New Jersey, United States
Renal Associates of Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Boise Kidney & Hypertension, PLLC - Meridian
🇺🇸Caldwell, Idaho, United States
South Carolina Nephrology & Hypertension Center Inc.
🇺🇸Orangeburg, South Carolina, United States
Columbia Nephrology Associates, P.A.
🇺🇸Columbia, South Carolina, United States
DCI - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Genesis Clinical Trials
🇺🇸Tampa, Florida, United States
Renal Medicine Associates
🇺🇸Albuquerque, New Mexico, United States
Paragon Health PC - Nephrology Center
🇺🇸Kalamazoo, Michigan, United States
US Renal Care - Westover Hills
🇺🇸San Antonio, Texas, United States
Southeastern Nephrology Associates - Wilmington
🇺🇸Wilmington, North Carolina, United States
DaVita Clinical Research - Santa Fe Spring
🇺🇸Montebello, California, United States
American Institute of Research
🇺🇸Whittier, California, United States
South Florida Research Institute
🇺🇸Lauderdale Lakes, Florida, United States
Polack Renal, LLC (SMO)
🇺🇸Saint Louis, Missouri, United States
Mountain Kidney and Hypertension Associates
🇺🇸Asheville, North Carolina, United States
U.S. Renal Care - Gallup
🇺🇸Gallup, New Mexico, United States
Dialysis Clinic, Inc - Kansas City
🇺🇸Kansas City, Missouri, United States
Omega Research Consultants, LLC
🇺🇸Orlando, Florida, United States
Clinical Research Consultants, LLC
🇺🇸Kansas City, Missouri, United States
Horizon Research Group - Coral Gables
🇺🇸Coral Gables, Florida, United States