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A Study to Evaluate Chitosan Chewing Gum in Patients With Chronic Kidney Disease

NCT01475760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2012-08-02

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of chitosan chewing gum (K2CG) in reducing serum phosphorus in subjects with chronic kidney disease.

Conditions

Interventions

OTHER

K2CG chewing gum (20mg chitosan)

All participating subjects will chew gum TID for 14 days beginning on Day 1 through Day 14

OTHER

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

Sponsors & Collaborators

  • CM&D Pharma Limited

    collaborator INDUSTRY

  • Denver Nephrologists, P.C.

    lead OTHER

Principal Investigators

  • Geoffrey Block, MD · DenverNephrologists, P.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

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 NCT01475760 on ClinicalTrials.gov