NCT01057108

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

A Double Blind, Randomized, Placebo Controlled Trial to Evaluate the Efficacy and Safety of FOSTRAP Chewing Gum in Patients With Chronic Kidney Disease and Hyperphosphatemia.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Denver Nephrologists, P.C. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hyperphosphatemia
• Chronic Kidney Disease

Interventions

Type	Name	Description
OTHER	FOSTRAP Chewing Gum	20 mg BID
OTHER	FOSTRAP Chewing Gum	40 mg BID
OTHER	FOSTRAP Chewing Gum	20 mg TID
OTHER	FOSTRAP Chewing Gum	20 mg TID
OTHER	Placebo chewing gum

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-01-27
• Last updated: 2011-01-07

Locations

1 site across 1 country: United States