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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:January 2016
Contact:Lee Berman
Email:lee.berman@frenovarenalresearch.com

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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)

This phase 2b, 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.

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.

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
We found this trial at
31
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Albuquerque, New Mexico 87108
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Asheville, North Carolina 28801
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Austin, Texas 78758
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Bellville, Texas 77418
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Bethesda, Maryland 20814
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Bethlehem, Pennsylvania 18017
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Bronx, New York 10803
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Brookhaven, Mississippi 39601
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Charlotte, North Carolina 28210
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Columbia, South Carolina 29203
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Columbus, Mississippi 39705
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Denver, Colorado 80230
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Huntsville, Alabama 35801
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Kalamazoo, Michigan 49008
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Knoxville, Tennessee 37909
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Lauderdale Lakes, Florida 33313
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Meridian, Idaho 83642
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Miami, Florida 33186
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Nashville, Tennessee 37211
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New Bern, North Carolina 28562
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Orangeburg, South Carolina 29118
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Raleigh, North Carolina 27609
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Riverside, California 92505
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Roseville, Michigan 48066
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San Antonio, Texas 78215
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Shreveport, Louisiana 71101
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St. George, Utah 84790
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St. Louis, Missouri 63136
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Sumter, South Carolina 29150
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Tupelo, Mississippi 38801
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Wilmington, North Carolina 28403
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