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Double Blind Randomized Placebo Controlled Trial of FOSTRAP Chewing Gum in Patients With CKD and Hyperphosphatemia

2014-08-27 03:16:21 | BioPortfolio

Summary

The phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce serum levels of phosphorus in patients with chronic kidney disease. We are testing this hypothesis using a chewing gum called FOSTRAP which has been shown to be effective in a small, non-randomized study in patients with chronic kidney disease on hemodialysis.

Description

A double-blind, randomized, placebo, controlled trial with an open label extension for those subjects with end stage renal disease (ESRD).

Patients with ESRD will be randomized to receive either FOSTRAP™ 20 mg BID, FOSTRAP™ 40 mg BID or matching placebo 2x/day. All subjects will participate in a 4 week chewing period followed by a 4 week follow up period. All subjects will then enter an open label 2 week extension phase in which they will receive FOSTRAP™ 20 mg TID.

Patients with chronic kidney disease (CKD) not on dialysis will receive either FOSTRAP™ 20 mg 3x/day or placebo TID for 4 weeks followed by a 4 week follow up period.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hyperphosphatemia

Intervention

FOSTRAP Chewing Gum, FOSTRAP Chewing Gum, FOSTRAP Chewing Gum, FOSTRAP Chewing Gum, Placebo chewing gum

Location

Denver Nephrologists, PC
Denver
Colorado
United States
80230

Status

Recruiting

Source

Denver Nephrologists, P.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:21-0400

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Chewing gum which contains NICOTINE.

The act and process of chewing and grinding food in the mouth.

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Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...


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