HyperphosphatemiaNCT01319578
PD Study to Assess Phosphate Binding Characteristics of K2CG Chewing Gum
A study testing K2CG chewing gum in people with Hyperphosphatemia and Chronic Kidney Disease, run by Denver Nephrologists, P.C. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia, Chronic Kidney Disease
- What is being tested?
- K2CG chewing gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Being tested
- K2CG chewing gum
- Keywords
- chronic kidney disease, phosphorus, phosphate, saliva, K2CG, medical food, chitosan
- Medical subject headings
- Hyperphosphatemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K2CG chewing gumOther
Fasting: Chew gum 15 minutes Post meal: Begin chewing 45 minutes post meal
K2CG chewing gumOther
Fasting: Chew gum 30 minutes Post meal: Begin chewing 30 minutes post meal
K2CG chewing gumOther
Fasting: Chew gum for 45 minutes Post meal: Begin chewing gum 15 minutes post meal
K2CG chewing gumOther
Fasting: Chew gum for 60 minutes Post meal: Being chewing gum 5 minutes post meal
| Study group | Role | What they receive |
|---|---|---|
| Chewing Arm 1 | Active comparator | Not described Receives: Other: K2CG chewing gum |
| Chewing Arm 2 | Placebo comparator | Not described Receives: Other: K2CG chewing gum |
| Chewing Arm 3 | Active comparator | Not described Receives: Other: K2CG chewing gum |
| Chewing Arm 4 | Active comparator | Not described Receives: Other: K2CG chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 min, 15 min, 30 min, 45 minutes post meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Denver Nephrologists, P.C.
- Sponsor type
- University, hospital or other
- Collaborators
- CM&D Pharma Limited
- Investigators
- Geoffrey A Block, MD, Principal investigator, Denver Nephrologists, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319578
- Sponsor's protocol ID
- CMD 005
- Status last verified
- Nov 2011
- First submitted
- 3 Mar 2011
- Last updated
- 15 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23797006
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind Pharmacodynamic Study to Assess the Phosphate Binding Characteristics of K2CG Chewing Gum
- ClinicalTrials.gov ID
- NCT01319578
- Acronym / sponsor ID
- CMD 005
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Keywords
- chronic kidney disease, phosphorus, phosphate, saliva, K2CG, medical food, chitosan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Denver Nephrologists, P.C.University, hospital or other
- Collaborators
- CM&D Pharma Limited
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K2CG chewing gumFasting: Chew gum 15 minutes Post meal: Begin chewing 45 minutes post meal | Other | Chewing Arm 1, Chewing Arm 2, Chewing Arm 3, Chewing Arm 4 |
| K2CG chewing gumFasting: Chew gum 30 minutes Post meal: Begin chewing 30 minutes post meal | Other | Chewing Arm 1, Chewing Arm 2, Chewing Arm 3, Chewing Arm 4 |
| K2CG chewing gumFasting: Chew gum for 45 minutes Post meal: Begin chewing gum 15 minutes post meal | Other | Chewing Arm 1, Chewing Arm 2, Chewing Arm 3, Chewing Arm 4 |
| K2CG chewing gumFasting: Chew gum for 60 minutes Post meal: Being chewing gum 5 minutes post meal | Other | Chewing Arm 1, Chewing Arm 2, Chewing Arm 3, Chewing Arm 4 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2011.
- Derived from this study: PubMed 23797006Block 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey A Block, MD principal investigator
Denver Nephrologists, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K2CG chewing gum in people with Hyperphosphatemia and Chronic Kidney Disease, run by Denver Nephrologists, P.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total phosphate bound per gum piece fasting (time frame: 15 min, 30 min, 45 min, 60 min post chewing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01319578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2011.