NCT01319578

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 21, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 15, 2011

Status Verified

November 1, 2011

Enrollment Period

1 month

First QC Date

March 3, 2011

Last Update Submit

November 11, 2011

Conditions

HyperphosphatemiaChronic Kidney Disease

Keywords

chronic kidney diseasephosphorusphosphatesalivaK2CGmedical foodchitosan

Outcome Measures

Primary Outcomes (2)

  • total phosphate bound per gum piece fasting

    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

    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

Study Arms (4)

Chewing Arm 1

ACTIVE COMPARATOR
Other: K2CG chewing gum

Chewing Arm 2

PLACEBO COMPARATOR
Other: K2CG chewing gum

Chewing Arm 3

ACTIVE COMPARATOR
Other: K2CG chewing gum

Chewing Arm 4

ACTIVE COMPARATOR
Other: K2CG chewing gum

Interventions

K2CG chewing gumOTHER

Fasting: Chew gum 15 minutes Post meal: Begin chewing 45 minutes post meal

Chewing Arm 1Chewing Arm 2Chewing Arm 3Chewing Arm 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Nephrologists, PC

Denver, Colorado, 80230, United States

Location

Related Publications (1)

  • Block GA, Persky MS, Shamblin BM, Baltazar MF, Singh B, Sharma A, Pergola P, Smits G, Comelli MC. Effect of salivary phosphate-binding chewing gum on serum phosphate in chronic kidney disease. Nephron Clin Pract. 2013;123(1-2):93-101. doi: 10.1159/000351850. Epub 2013 Jun 22.

    PMID: 23797006DERIVED

MeSH Terms

Conditions

HyperphosphatemiaRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Geoffrey A Block, MD

    Denver Nephrologists, PC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 21, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 15, 2011

Record last verified: 2011-11

Locations

US(1)