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A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03427125
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Ardelyx

Tracking Information
First Submitted Date  ICMJE January 19, 2018
First Posted Date  ICMJE February 9, 2018
Last Update Posted Date April 1, 2020
Actual Study Start Date  ICMJE January 8, 2018
Actual Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
Change in serum phosphorus levels during placebo controlled randomized withdrawal period in the responder population [ Time Frame: 12 weeks (randomized withdrawal period) ]
Placebo adjusted change in serum phosphorus from the beginning to the end of the randomized withdrawal period in patients with at least a 1.2 mg/dL decrease in serum phosphorus (responder population) during the first 26 weeks of the study
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
  • Change in serum phosphorus levels during placebo controlled randomized withdrawal period in the ITT Population [ Time Frame: 12 weeks (randomized withdrawal period) ]
    Placebo Adjusted Change in Serum Phosphorus from the beginning to the end of the Randomized Withdrawal Period in all patients
  • Change in serum phosphorus from Baseline [ Time Frame: 26 weeks (open label treatment period) ]
    change from baseline (post washout) to end of 26 week period
  • Effect of Tenapanor on serum FGF23 levels [ Time Frame: 52 weeks ]
    Change from baseline to end of different treatment periods
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis
Official Title  ICMJE A 26-Wk, Phase 3, Open Label Study With a 12-Wk, Placebo-Controlled, Randomized Withdrawal Period Followed by an Open Label Long Term Safety Extension to Evaluate the Safety and Efficacy of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis
Brief Summary This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized withdrawal period followed by an open label long term safety extension will evaluate the safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD) on hemodialysis and peritoneal dialysis.
Detailed Description

The study consists of a screening visit, a phosphate binder-free washout period of up to 4 weeks, a 26-week treatment period, an up to 12-week placebo-controlled, randomized withdrawal period, during which patients are randomized 1:1 to either remain on their tenapanor treatment or placebo, followed by an open label safety extension period for a total treatment period of up to 52 weeks. An active control group, for safety analysis only, will receive sevelamer carbonate, open label, for the entire 52-week study period

Depending on increase in serum phosphate (s-P) levels, subjects can be randomized 2 or 3 weeks after being taken off their phosphate lowering medication.

Subjects who qualify to enroll in the study will be randomized 3:1 to either receive tenapanor at a dose of 30 mg bid or sevelamer carbonate.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyperphosphatemia
Intervention  ICMJE
  • Drug: Tenapanor
    Active Drug
    Other Name: RDX5791, AZD1722
  • Drug: Placebo
    Inactive Drug
  • Drug: Sevelamer Carbonate
    Active control
    Other Name: Standard of Care
Study Arms  ICMJE
  • Experimental: Tenapanor 10 mg, 20 mg, 30 mg BID
    During the 26-week open label part, all enrolled subjects will receive 30 mg BID doses of tenapanor. Investigators may decrease or increase the dose in 10 mg increments to a minimum of 10 g BIDor a maximum of 30 mg BID
    Intervention: Drug: Tenapanor
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Sevelamer Carbonate
    Subjects randomized into the active control group, for safety analysis, will receive sevelamer carbonate, open label, for the entire 52-week study period. Sevelamer carbonate will be dosed based on package insert instructions (standard of care)
    Intervention: Drug: Sevelamer Carbonate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2019)
564
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2018)
560
Actual Study Completion Date  ICMJE February 27, 2020
Actual Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 a week for at least 3 months
  • Chronic maintenance peritoneal dialysis for a minimum of 6 months
  • Kt/V ≥ 1.2 at most recent measurement prior to screening
  • Prescribed and taking at least 3 doses of phosphate binder per day
  • Serum phosphorus levels should be between 4.0 and 8.0 mg/dL at screening
  • Unchanged dose of vitamin D or calcimimetics for the last 4 weeks prior to screening
  • For enrollment in the study after at least 2 weeks of wash-out, subjects must have serum phosphorus levels of at least 6.0 mg/dL but not more than 10.0 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value after 2 or 3 weeks wash-out of phosphate binders

Exclusion Criteria:

  • Severe hyperphosphatemia defined as serum phosphorus greater than 10.0 mg/dL on phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening visit
  • Serum/plasma parathyroid hormone >1200 pg/mL
  • Clinical signs of hypovolemia at enrollment
  • History of IBD or 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
  • Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator
  • Life expectancy <6 months
  • Previous exposure to tenapanor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03427125
Other Study ID Numbers  ICMJE TEN-02-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ardelyx
Study Sponsor  ICMJE Ardelyx
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ardelyx
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP