PD Study to Assess Phosphate Binding Characteristics of K2CG Chewing Gum

November 11, 2011 updated by: Denver Nephrologists, P.C.

A Single Blind Pharmacodynamic Study to Assess the Phosphate Binding Characteristics of K2CG Chewing Gum

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous studies have demonstrated that salivary phosphate levels are elevated in patients with CKD and that there is a direct and linear correlation between serum phosphorus and salivary phosphorus. K2CG chewing gum may provide an alternative approach to treating patients with elevated phosphate levels. However, data regarding the pharmacodynamic effect of the K2CG chewing gum on salivary phosphorus is lacking; as such, this study seeks to examine the phosphate binding characteristics of K2CG chewing gum with 2 different amounts of chitosan and varying exposure time in the fasting and fed condition.

A precise knowledge of the pharmacodynamic effect of the K2CG chewing gum on salivary phosphorus is expected to provide information necessary to plan and conduct a subsequent interventional trial with K2CG chewing gum in patients with both Chronic Kidney Disease and ESRD. Specifically, quantification of the amount of salivary phosphorus that binds to 3 formulations of chitosan loaded chewing gum (20 mg, 40 mg and 60 mg) with varying exposure times will inform the optimal duration of exposure relative to gum size. The effect of gum size will be further explored via the use of two different sizes of placebo chewing gum (1.7 g and 2.0 g sizes). Additionally it is a specific aim of this study to assess whether chewing gum in the fasted vs. fed state affects the binding characteristics of chitosan loaded chewing gum.

This study is a pharmacodynamic study to characterize the phosphate binding capabilities of three different doses of K2CG chewing gum (20mg, 40mg, 60mg) and one placebo chewing gum (1.7 g). Thirty-six subjects will be enrolled across three renal function group based on estimated glomerular filtration rate.

Study assessments will occur over four study visit days (Visit 2, Visit 3, Visit 4, and Visit 5). Fasting study procedures will occur in the morning of each visit day, and non-fasting procedures will occur following the administration of a standardized meal on the same day. All subjects will receive three doses of K2CG chewing gum and one placebo: 20 mg dose at Visit 2, 1.7 g placebo at Visit 3, 40 mg dose at Visit 4, and 60 mg dose at Visit 5. Subjects will not be aware of the specific gum dose or size at any study visit (single blind). The duration of gum chewing and timing of salivary collections will vary within each group.

Saliva will be collected at specified time points throughout the trial. Fasting salivary phosphorus must be collected with nothing to eat or drink for at least 2 hours.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Nephrologists, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Chewing Arm 1
Other: K2CG chewing gum
Fasting: Chew gum 15 minutes Post meal: Begin chewing 45 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum 30 minutes Post meal: Begin chewing 30 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum for 45 minutes Post meal: Begin chewing gum 15 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum for 60 minutes Post meal: Being chewing gum 5 minutes post meal
Placebo Comparator: Chewing Arm 2
Other: K2CG chewing gum
Fasting: Chew gum 15 minutes Post meal: Begin chewing 45 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum 30 minutes Post meal: Begin chewing 30 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum for 45 minutes Post meal: Begin chewing gum 15 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum for 60 minutes Post meal: Being chewing gum 5 minutes post meal
Active Comparator: Chewing Arm 3
Other: K2CG chewing gum
Fasting: Chew gum 15 minutes Post meal: Begin chewing 45 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum 30 minutes Post meal: Begin chewing 30 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum for 45 minutes Post meal: Begin chewing gum 15 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum for 60 minutes Post meal: Being chewing gum 5 minutes post meal
Active Comparator: Chewing Arm 4
Other: K2CG chewing gum
Fasting: Chew gum 15 minutes Post meal: Begin chewing 45 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum 30 minutes Post meal: Begin chewing 30 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum for 45 minutes Post meal: Begin chewing gum 15 minutes post meal
Other: K2CG chewing gum
Fasting: Chew gum for 60 minutes Post meal: Being chewing gum 5 minutes post meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total phosphate bound per gum piece fasting
Time Frame: 15 min, 30 min, 45 min, 60 min post chewing
patients will be assigned to treatment arms of varying chewing duration fasting and the total phosphorous bound per piece of chewing gum will be assessed. each patient will recieve (in random order) gum with placebo, 20 mg, 40 mg, and 60 mg chitosan content
15 min, 30 min, 45 min, 60 min post chewing
total phosphate bound per piece of gum post meal
Time Frame: 5 min, 15 min, 30 min, 45 minutes post meal
Each subject will begin chewing at the assigned time post meal exposure and chew for 30 minutes. total phosphorus bound per piece of gum will be assessed. each patient will recieve (in random order) gum with placebo, 20 mg, 40 mg, and 60 mg chitosan content
5 min, 15 min, 30 min, 45 minutes post meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denver Nephrologists, P.C.

Collaborators

CM&D Pharma Limited

Investigators

  • Principal Investigator: Geoffrey A Block, MD, Denver Nephrologists, PC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 3, 2011

First Submitted That Met QC Criteria

March 18, 2011

First Posted (Estimate)

March 21, 2011

Study Record Updates

Last Update Posted (Estimate)

November 15, 2011

Last Update Submitted That Met QC Criteria

November 11, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMD 005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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