Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects With Hyperphosphatemia
1 other identifier
interventional
236
1 country
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2019
Shorter than P25 for phase_2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2019
CompletedFirst Posted
Study publicly available on registry
January 31, 2019
CompletedStudy Start
First participant enrolled
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2019
CompletedResults Posted
Study results publicly available
March 6, 2023
CompletedMarch 6, 2023
February 1, 2023
5 months
January 29, 2019
December 7, 2022
February 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.
Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.
4 Weeks (28 days randomization period; from baseline to week 4)
Secondary Outcomes (3)
s-P Response at Week 4
4 Weeks (28 days randomization period)
Relative Change From Baseline in iFGF23 at Week 4
4 Weeks (28 days randomization period)
Relative Change From Baseline in cFGF23 at Week 4
4 Weeks (28 days randomization period)
Study Arms (2)
Tenapanor 30 mg BID
EXPERIMENTALDuring 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 COMPARATORsame size, weight and appearance of experimental drug
Interventions
standard of care phosphate binder use at study entry was maintained throughout the entire study
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ardelyxlead
Study Sites (48)
Nephrology Consultants, LLC
Huntsville, Alabama, 35805, United States
US Renal Care Pine Bluff
Pine Bluff, Arkansas, 71603, United States
Southeast Renal Research
Beverly Hills, California, 90211, United States
California Institute of Renal Research - Chula Vista
Chula Vista, California, 91910, United States
North America Research Institute
Lynwood, California, 90262, United States
DaVita Clinical Research - Santa Fe Spring
Montebello, California, 90640, United States
Central Coast Nephrology
Salinas, California, 93901, United States
North America Research Institute - San Dimas
San Dimas, California, 91773, United States
Chabot Nephrology Medical Group
Union City, California, 94587, United States
American Institute of Research
Whittier, California, 90603, United States
Nova Clinical Research, LLC
Bradenton, Florida, 34209, United States
Horizon Research Group - Coral Gables
Coral Gables, Florida, 33134, United States
South Florida Research Institute
Lauderdale Lakes, Florida, 33313, United States
Total Research Group, LLC
Miami, Florida, 33126, United States
Omega Research Consultants, LLC
Orlando, Florida, 32810, United States
Genesis Clinical Trials
Tampa, Florida, 33614, United States
Dialysis Clinic, Inc - Albany GA
Albany, Georgia, 31701, United States
Boise Kidney & Hypertension, PLLC - Meridian
Caldwell, Idaho, 83605, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
Dialysis Clinic, Inc - Boston/Somerville
Boston, Massachusetts, 02111, United States
Paragon Health PC - Nephrology Center
Kalamazoo, Michigan, 49007, United States
InterMed Consultants
Minneapolis, Minnesota, 55404, United States
Nephrology and Hypertension Associates, LTD
Tupelo, Mississippi, 38801, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111, United States
Dialysis Clinic, Inc - Kansas City
Kansas City, Missouri, 64131, United States
Polack Renal, LLC (SMO)
St Louis, Missouri, 63121, United States
Kidney Specialists of Southern Nevada
Las Vegas, Nevada, 89107, United States
Sierra Nevada Nephrology Consultants
Reno, Nevada, 89511, United States
Dialysis Clinic, Inc - North Brunswick
North Brunswick, New Jersey, 08902, United States
Renal Medicine Associates
Albuquerque, New Mexico, 87109, United States
U.S. Renal Care - Gallup
Gallup, New Mexico, 87301, United States
Northwell Health
Great Neck, New York, 11021, United States
Mountain Kidney and Hypertension Associates
Asheville, North Carolina, 28801, United States
Mountain Kidney & Hypertension Associates, P.A.
Asheville, North Carolina, 28805, United States
Durham Nephrology Associates
Durham, North Carolina, 27704, United States
Southeastern Nephrology Associates - Wilmington
Wilmington, North Carolina, 28401, United States
University of Cincinnati (UC) - Department of Nephrology
Cincinnati, Ohio, 45267, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017, United States
Columbia Nephrology Associates, P.A.
Columbia, South Carolina, 29203, United States
South Carolina Nephrology & Hypertension Center Inc.
Orangeburg, South Carolina, 29118, United States
DCI - Spartanburg
Spartanburg, South Carolina, 29301, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923, United States
Med Center Dialysis
Houston, Texas, 77004, United States
US Renal Care - Waxahachie
Mansfield, Texas, 76063, United States
US Renal Care - Mesquite
Mesquite, Texas, 75150, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212, United States
US Renal Care - Pleasanton Road
San Antonio, Texas, 78221, United States
US Renal Care - Westover Hills
San Antonio, Texas, 78251, United States
Related Publications (2)
Sprague SM, Weiner DE, Tietjen DP, Pergola PE, Fishbane S, Block GA, Silva AL, Fadem SZ, Lynn RI, Fadda G, Pagliaro L, Zhao S, Edelstein S, Spiegel DM, Rosenbaum DP. Tenapanor as Therapy for Hyperphosphatemia in Maintenance Dialysis Patients: Results from the OPTIMIZE Study. Kidney360. 2024 May 1;5(5):732-742. doi: 10.34067/KID.0000000000000387. Epub 2024 Feb 7.
PMID: 38323855DERIVEDPergola PE, Rosenbaum DP, Yang Y, Chertow GM. A Randomized Trial of Tenapanor and Phosphate Binders as a Dual-Mechanism Treatment for Hyperphosphatemia in Patients on Maintenance Dialysis (AMPLIFY). J Am Soc Nephrol. 2021 Jun 1;32(6):1465-1473. doi: 10.1681/ASN.2020101398. Epub 2021 Mar 25.
PMID: 33766811DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Development Officer
- Organization
- Ardelyx
Study Officials
- STUDY CHAIR
David P Rosenbaum, PhD
Ardelyx
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2019
First Posted
January 31, 2019
Study Start
February 28, 2019
Primary Completion
July 17, 2019
Study Completion
July 17, 2019
Last Updated
March 6, 2023
Results First Posted
March 6, 2023
Record last verified: 2023-02