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An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

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ClinicalTrials.gov Identifier: NCT02675998
Recruitment Status : Completed
First Posted : February 5, 2016
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Ardelyx

Brief Summary:
This phase 3, 8-week, randomized, double-blind, parallel group, multi-center study with a 4-week, placebo-controlled, randomized withdrawal period will evaluate the efficacy, safety and tolerability of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients on hemodialysis (ESRD-HD). Subjects who qualify are randomized into the study will either receive 3 mg BID, 10 mg BID, or a titration regimen of tenapanor.

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

Detailed Description:

The study consists of a screening visit, a wash out period of up to 3 weeks, when existing phosphate lowering medication is withheld, an 8-week treatment period, in which all groups receive tenapanor, and a 4-week placebo-controlled, randomized withdrawal period, during which patients are re-randomized 1:1 to either remain on their current tenapanor treatment or placebo.

Depending on the increase in serum phosphate levels, subjects can be randomized 1,2, or 3 weeks after being taken off their phosphate lowering medication.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: An 8-week, Multicenter, Randomized, Double-Blind, Parallel Group Study With a 4-week, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Efficacy, Safety, and Tolerability of Tenapanor to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
Study Start Date : January 2016
Actual Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3mg BID
Tenapanor, 3mg BID (6mg total)
Drug: Tenapanor
Other Name: RDX5791, AZD1722

Experimental: 10mg BID
Tenapanor, 10mg BID (20mg total)
Drug: Tenapanor
Other Name: RDX5791, AZD1722

Experimental: Dose Titration
Tenapanor, patients start at 30mg BID and can down titrate weekly to 20, 15, 10, and 3mg BID, sequentially based on a GI tolerability question
Drug: Tenapanor
Other Name: RDX5791, AZD1722

Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Change in Serum Phosphate from Baseline [ Time Frame: 8 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:

  • 18 to 80 years old
  • 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/week for at least 3 months
  • Kt/V ≥ 1.3 at most recent measurement prior to screening
  • Prescribed and taking at least 3 doses of phosphate binder per day
  • Serum phosphate levels should be between 4.0 and 7.0 mg/dL (inclusive) at screening
  • For randomization in the study, after 1 week wash-out of phosphate binders, subjects must have serum phosphate level of at least 9 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value
  • For randomization in the study, after 2 or 3 weeks wash-out of phosphate binders, subjects must have serum phosphate level of at least 6 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value

Exclusion Criteria:

  • Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening
  • Serum parathyroid hormone >1200 pg/mL
  • Persistent metabolic acidosis defined as serum carbon dioxide <18 mmol/L from two consecutive measurements during screening and washout periods
  • Clinical signs of hypovolemia at randomization
  • History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome (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
  • Diarrhea or loose stools during the week before randomization defined as BSFS ≥ 6 and frequency ≥ 3 for 2 or more days
  • Any evidence of or treatment of malignancy within one year, excluding non-melanomatous malignancies of the skin
  • Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator
  • Life expectancy < 6 months

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): NCT02675998


  Show 32 Study Locations
Sponsors and Collaborators
Ardelyx
Investigators
Study Chair: David P Rosenbaum, Ph.D. Ardelyx, Inc.

Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT02675998     History of Changes
Other Study ID Numbers: TEN-02-201
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases