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

Hyperphosphatemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824587
• Other study ID #: TEN-02-202
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 28, 2019
• Est. completion date: July 17, 2019

Study information

• Verified date: February 2023
• Source: Ardelyx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• Tenapanor
Active Drug
• Placebo
Inactive Drug
• Phosphate Binder Agents
standard of care phosphate binder use at study entry was maintained throughout the entire study

Locations

Country	Name	City	State
United States	Dialysis Clinic, Inc - Albany GA	Albany	Georgia
United States	Renal Medicine Associates	Albuquerque	New Mexico
United States	Mountain Kidney & Hypertension Associates, P.A.	Asheville	North Carolina
United States	Mountain Kidney and Hypertension Associates	Asheville	North Carolina
United States	Renal Associates of Baton Rouge	Baton Rouge	Louisiana
United States	Northeast Clinical Research Center	Bethlehem	Pennsylvania
United States	Southeast Renal Research	Beverly Hills	California
United States	Dialysis Clinic, Inc - Boston/Somerville	Boston	Massachusetts
United States	Nova Clinical Research, LLC	Bradenton	Florida
United States	Boise Kidney & Hypertension, PLLC - Meridian	Caldwell	Idaho
United States	California Institute of Renal Research - Chula Vista	Chula Vista	California
United States	University of Cincinnati (UC) - Department of Nephrology	Cincinnati	Ohio
United States	Columbia Nephrology Associates, P.A.	Columbia	South Carolina
United States	Horizon Research Group - Coral Gables	Coral Gables	Florida
United States	Durham Nephrology Associates	Durham	North Carolina
United States	U.S. Renal Care - Gallup	Gallup	New Mexico
United States	Northwell Health	Great Neck	New York
United States	Med Center Dialysis	Houston	Texas
United States	Nephrology Consultants, LLC	Huntsville	Alabama
United States	Paragon Health PC - Nephrology Center	Kalamazoo	Michigan
United States	Clinical Research Consultants, LLC	Kansas City	Missouri
United States	Dialysis Clinic, Inc - Kansas City	Kansas City	Missouri
United States	Knoxville Kidney Center, PLLC	Knoxville	Tennessee
United States	Kidney Specialists of Southern Nevada	Las Vegas	Nevada
United States	South Florida Research Institute	Lauderdale Lakes	Florida
United States	North America Research Institute	Lynwood	California
United States	US Renal Care - Waxahachie	Mansfield	Texas
United States	US Renal Care - Mesquite	Mesquite	Texas
United States	Total Research Group, LLC	Miami	Florida
United States	InterMed Consultants	Minneapolis	Minnesota
United States	DaVita Clinical Research - Santa Fe Spring	Montebello	California
United States	Dialysis Clinic, Inc - North Brunswick	North Brunswick	New Jersey
United States	South Carolina Nephrology & Hypertension Center Inc.	Orangeburg	South Carolina
United States	Omega Research Consultants, LLC	Orlando	Florida
United States	US Renal Care Pine Bluff	Pine Bluff	Arkansas
United States	Sierra Nevada Nephrology Consultants	Reno	Nevada
United States	Polack Renal, LLC (SMO)	Saint Louis	Missouri
United States	Central Coast Nephrology	Salinas	California
United States	Clinical Advancement Center, PLLC	San Antonio	Texas
United States	US Renal Care - Pleasanton Road	San Antonio	Texas
United States	US Renal Care - Westover Hills	San Antonio	Texas
United States	North America Research Institute - San Dimas	San Dimas	California
United States	DCI - Spartanburg	Spartanburg	South Carolina
United States	Genesis Clinical Trials	Tampa	Florida
United States	Nephrology and Hypertension Associates, LTD	Tupelo	Mississippi
United States	Chabot Nephrology Medical Group	Union City	California
United States	American Institute of Research	Whittier	California
United States	Southeastern Nephrology Associates - Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ardelyx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	s-P Response at Week 4	Achieving an s-P level <5.5 mg/dL	4 Weeks (28 days randomization period)
Secondary	Relative Change From Baseline in iFGF23 at Week 4	iFGF23 at Week 4/baseline iFGF23 - 1	4 Weeks (28 days randomization period)
Secondary	Relative Change From Baseline in cFGF23 at Week 4	cFGF23 at Week 4/baseline cFGF23 - 1	4 Weeks (28 days randomization period)