NCT01341691

Brief Summary

To determine the amount of phosphate recovered into 2 strengths of K2CG chewing gum in a modified formulation (with or without an extender) added to the gum core, in comparison to matching placebo gums.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2011

Shorter than P25 for early_phase_1

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

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2011

Completed
Last Updated

April 26, 2011

Status Verified

April 1, 2011

Enrollment Period

1 month

First QC Date

April 23, 2011

Last Update Submit

April 25, 2011

Conditions

Chronic Kidney Disease

Keywords

chronic kidney diseaseK2CG chewing gumphosphorussaliva

Outcome Measures

Primary Outcomes (1)

  • Total phosphorus bound and entrapped per piece of chewing gum

    Each subject will chew a single piece of chewing gum for 60 minutes, twice daily for 1 week and all gum is collected and analyzed individually.

    60 minutes

Study Arms (6)

Placebo 20mg

PLACEBO COMPARATOR
Other: chewing gum

K2CG 60 mg extender

ACTIVE COMPARATOR
Other: chewing gum

K2CG 60 mg

ACTIVE COMPARATOR
Other: chewing gum

K2CG 20mg extender

ACTIVE COMPARATOR
Other: chewing gum

K2CG 20mg

ACTIVE COMPARATOR
Other: chewing gum

Placebo 60mg

PLACEBO COMPARATOR
Other: chewing gum

Interventions

chewing gumOTHER

single piece of chewing gum containing specified amount of chitosan with or without extender chewed twice daily for 14 days

K2CG 20mgK2CG 20mg extenderK2CG 60 mgK2CG 60 mg extenderPlacebo 20mgPlacebo 60mg

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;
  • The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB);
  • The subject will, in the opinion of the investigator, be compliant with prescribed therapy;
  • Subject must be able to communicate and be able to understand and comply with the requirements of the study;
  • Subject must be prescribed a diet appropriate for patients with their stage of CKD and must be willing to avoid intentional changes in diet; and
  • Subject must have completed the CMD002 clinical trial and is currently receiving hemodialysis.

You may not qualify if:

  • Subject is receiving or has received an investigational product (or is currently using an investigational device) within 7 days prior to baseline;
  • Subject has a known sensitivity to chitin or allergy to shellfish;
  • Subject has a clinically significant infection requiring treatment with antibiotics (within 7 days prior to baseline);
  • Subject has had an inpatient hospitalization within 7 days prior to baseline with the exception of hospitalizations related to vascular access procedures; In the opinion of the investigator, subject is unable to chew gum for 60 minutes; and
  • Subject has an unstable medical condition which in the opinion of the investigator would compromise successful completion of the study;

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

Renal Insufficiency, Chronic

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Geoffrey A Block, MD

    Denver Nephrologists, PC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2011

First Posted

April 26, 2011

Study Start

March 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 26, 2011

Record last verified: 2011-04

Locations

US(1)