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Trial record 2 of 5 for:    ardelyx | Hyperphosphatemia

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

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ClinicalTrials.gov Identifier: NCT03824587
Recruitment Status : Active, not recruiting
First Posted : January 31, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Drug: Tenapanor Drug: Placebo Phase 2 Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: Tenapanor 30 mg BID

During the Double-Blind Treatment Period, subjects will receive tenapanor or placebo 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.

Drug: Tenapanor
Active Drug

Placebo Comparator: Placebo Drug: Placebo
Inactive Drug




Primary Outcome Measures :
  1. Change in serum phosphorus (s-P) level from baseline and at Week 4. [ Time Frame: 4 Weeks (28 days randomization period) ]
    Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups.


Secondary Outcome Measures :
  1. s-P response at Week 4 [ Time Frame: 4 Weeks (28 days randomization period) ]
    Achieving an s-P level <5.5 mg/dL

  2. Relative change from baseline in iFGF23 at Week 4 [ Time Frame: 4 Weeks (28 days randomization period) ]
    iFGF23 at Week 4/baseline iFGF23 - 1

  3. Relative change from baseline in cFGF23 at Week 4 [ Time Frame: 4 Weeks (28 days randomization period) ]
    cFGF23 at Week 4/baseline cFGF23 - 1

  4. Change from baseline in s-P level at Week 1, Week 2, and Week 3 [ Time Frame: 4 weeks ]
    serum phosphorus change

  5. s-P response at Week 1, Week 2, and Week 3 [ Time Frame: 4 weeks ]
    number of patients with serum phosphorus below 5.5 mg/dL

  6. Change from baseline in PTH at Week 4 [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824587


  Show 48 Study Locations
Sponsors and Collaborators
Ardelyx
Investigators
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Study Chair: David P Rosenbaum, PhD Ardelyx

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Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT03824587     History of Changes
Other Study ID Numbers: TEN-02-202
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases