Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Hyperphosphatemia

In brief

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.

Key facts

Study ID

NCT03824587

Run by

Ardelyx

People needed

236

Starts

2019-02-28

Expected to finish

2019-07-17

Last updated by the study team

2023-03-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Nephrology Consultants, LLC — Huntsville, Alabama, United States
• US Renal Care Pine Bluff — Pine Bluff, Arkansas, United States
• Southeast Renal Research — Beverly Hills, California, United States
• California Institute of Renal Research - Chula Vista — Chula Vista, California, United States
• North America Research Institute — Lynwood, California, United States
• DaVita Clinical Research - Santa Fe Spring — Montebello, California, United States
• Central Coast Nephrology — Salinas, California, United States
• North America Research Institute - San Dimas — San Dimas, California, United States
• Chabot Nephrology Medical Group — Union City, California, United States
• American Institute of Research — Whittier, California, United States
• Nova Clinical Research, LLC — Bradenton, Florida, United States
• Horizon Research Group - Coral Gables — Coral Gables, Florida, United States
• South Florida Research Institute — Lauderdale Lakes, Florida, United States
• Total Research Group, LLC — Miami, Florida, United States
• Omega Research Consultants, LLC — Orlando, Florida, United States
• Genesis Clinical Trials — Tampa, Florida, United States
• Dialysis Clinic, Inc - Albany GA — Albany, Georgia, United States
• Boise Kidney & Hypertension, PLLC - Meridian — Caldwell, Idaho, United States
• Renal Associates of Baton Rouge — Baton Rouge, Louisiana, United States
• Dialysis Clinic, Inc - Boston/Somerville — Boston, Massachusetts, United States
• Paragon Health PC - Nephrology Center — Kalamazoo, Michigan, United States
• InterMed Consultants — Minneapolis, Minnesota, United States
• Nephrology and Hypertension Associates, LTD — Tupelo, Mississippi, United States
• Clinical Research Consultants, LLC — Kansas City, Missouri, United States
• Dialysis Clinic, Inc - Kansas City — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.