167
Participants
Start Date
November 30, 2011
Primary Completion Date
March 31, 2012
Study Completion Date
March 31, 2012
K2CG chewing gum (20mg chitosan)
All participating subjects will chew gum TID for 14 days beginning on Day 1 through Day 14
K2CG chewing gum (60mg chitosan)
"Subjects will be randomized in a 1:1 fashion to either chew gum or continue with Standard of Care (no intervention)if they have a change in serum phosphorus of greater than or equal to -0.2 mg/dL from:~Baseline (defined as the mean of values from Visit 2, 3, and 4) to the end of active treatment (defined as the mean of Visit 6 and 7) AND/OR Baseline (defined as the mean of values from Visit 2, 3, and 4) and end of wash out (defined as Visit 7 (Day 22).~If randomized: Chew gum TID for 14 days beginning on Day 29 through Day 42"
Renal Associates, PA, San Antonio
Denver Nephrologists, PC, Denver
Pacific Renal Research Institute, Meridian
Southwest Clinical Reserach Institute, LLC, Tempe
Collaborators (1)
CM&D Pharma Limited
INDUSTRY
Denver Nephrologists, P.C.
OTHER