MedTrace Logo

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

NCT01057108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2011-01-07

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • CM&D Pharma Limited

    collaborator INDUSTRY

  • Denver Nephrologists, P.C.

    lead OTHER

Principal Investigators

  • Geoffrey A Block, MD · Denver Nephrologists, PC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01057108 on ClinicalTrials.gov