PD Study to Assess Phosphate Binding Characteristics of K2CG Chewing Gum

Tracking Information
First Submitted Date ICMJE	March 3, 2011
First Posted Date ICMJE	March 21, 2011
Last Update Posted Date	November 15, 2011
Study Start Date ICMJE	July 2011
Actual Primary Completion Date	August 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 21, 2011)	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; 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
Original Primary Outcome Measures ICMJE; (submitted: March 18, 2011)	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 (2 sizes), 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 ]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 (2 sizes), 20 mg, 40 mg, and 60 mg chitosan content
Change History	Complete list of historical versions of study NCT01319578 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	PD Study to Assess Phosphate Binding Characteristics of K2CG Chewing Gum
Official Title ICMJE	A Single Blind Pharmacodynamic Study to Assess the Phosphate Binding Characteristics of K2CG Chewing Gum
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.
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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant)
Condition ICMJE	Hyperphosphatemia; Chronic Kidney Disease
Intervention ICMJE	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
Study Arms	Active Comparator: Chewing Arm 1 Interventions: Other: K2CG chewing gum Other: K2CG chewing gum Other: K2CG chewing gum Other: K2CG chewing gum; Placebo Comparator: Chewing Arm 2 Interventions: Other: K2CG chewing gum Other: K2CG chewing gum Other: K2CG chewing gum Other: K2CG chewing gum; Active Comparator: Chewing Arm 3 Interventions: Other: K2CG chewing gum Other: K2CG chewing gum Other: K2CG chewing gum Other: K2CG chewing gum; Active Comparator: Chewing Arm 4 Interventions: Other: K2CG chewing gum Other: K2CG chewing gum Other: K2CG chewing gum Other: K2CG chewing gum
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: March 18, 2011)	36
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	August 2011
Actual Primary Completion Date	August 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01319578
Other Study ID Numbers ICMJE	CMD 005
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Geoffrey A. Block, MD, Principal Investigator, Denver Nephrologists, PC
Study Sponsor ICMJE	Denver Nephrologists, P.C.
Collaborators ICMJE	CM&D Pharma Limited
Investigators ICMJE	Principal Investigator: Geoffrey A Block, MD Denver Nephrologists, PC
PRS Account	Denver Nephrologists, P.C.
Verification Date	November 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP