PD Study to Assess Phosphate Binding Characteristics of K2CG Chewing Gum

This study has been completed.
Sponsor:
Collaborator:
CM&D Pharma Limited
Information provided by:
Denver Nephrologists, P.C.
ClinicalTrials.gov Identifier:
NCT01319578
First received: March 3, 2011
Last updated: November 11, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Hyperphosphatemia
Chronic Kidney Disease
Other: K2CG chewing gum

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: A Single Blind Pharmacodynamic Study to Assess the Phosphate Binding Characteristics of K2CG Chewing Gum

Resource links provided by NLM:


Further study details as provided by Denver Nephrologists, P.C.:

Primary Outcome Measures:
  • total phosphate bound per gum piece fasting [ Time Frame: 15 min, 30 min, 45 min, 60 min post chewing ] [ Designated as safety issue: No ]
    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

  • total phosphate bound per piece of gum post meal [ Time Frame: 5 min, 15 min, 30 min, 45 minutes post meal ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 36
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01319578

Locations
United States, Colorado
Denver Nephrologists, PC
Denver, Colorado, United States, 80230
Sponsors and Collaborators
Denver Nephrologists, P.C.
CM&D Pharma Limited
Investigators
Principal Investigator: Geoffrey A Block, MD Denver Nephrologists, PC
  More Information

No publications provided by Denver Nephrologists, P.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Geoffrey A. Block, MD, Principal Investigator, Denver Nephrologists, PC
ClinicalTrials.gov Identifier: NCT01319578     History of Changes
Other Study ID Numbers: CMD 005
Study First Received: March 3, 2011
Last Updated: November 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Nephrologists, P.C.:
chronic kidney disease
phosphorus
phosphate
saliva
K2CG
medical food
chitosan

Additional relevant MeSH terms:
Kidney Diseases
Hyperphosphatemia
Renal Insufficiency, Chronic
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 19, 2014