PD Study to Assess Phosphate Binding Characteristics of K2CG Chewing Gum

Completed · Not applicable

Conditions studied: Hyperphosphatemia, Chronic Kidney Disease

In brief

The specific purpose of this study is to describe the characteristics of the K2CG chewing gum, specifically as it relates to duration of gum chewing (exposure), timing of gum chewing in relation to a meal, and dose of K2CG chewing gum.

Key facts

Study ID

NCT01319578

Run by

Denver Nephrologists, P.C.

People needed

36

Starts

2011-07-01

Expected to finish

2011-08-01

Last updated by the study team

2011-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women > 18 years of age;
• Must have no dietary restriction that would preclude eating standardized meal (both a meat based and vegan option available)
• The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB).
• Must be able to chew gum for at least 60 minutes.
• Must have historical eGFR appropriate for the study.

You may not qualify if…

• Receiving or has received an investigational product (or is currently using an investigational device) within 30 days prior to Visit 2;
• Evidence of active (clinically significant) infection at the time of study enrollment (in the opinion of the investigator);
• Dental work within 48 hours of enrollment (Visit 2); and
• Known sensitivity to chitin, or allergy to shellfish

Where it is running

• Denver Nephrologists, PC — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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