Chronic Kidney DiseaseEarly Phase 1NCT01341691
Phosphate Binding of Chitosan Chewing Gum in Patients With Chronic Kidney Disease (CKD)
A Early Phase 1 study testing chewing gum in people with Chronic Kidney Disease, run by Denver Nephrologists, P.C. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- chewing gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Apr 2011
- Phase
- Early Phase 1
- 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;
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2 Week Single Blind Study to Evaluate Phosphate Binding of Chitosan Chewing Gum in Patients With Chronic Kidney Disease
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.
Read the detailed description
The current treatment for elevated serum phosphorus levels in chronic kidney disease (CKD) consists of dietary restriction of P and the provision of phosphate binders that act at the level of the intestinal absorption of phosphorus (P) when ingested with meals. This paradigm has proven to be inadequate to achieve normo-phosphatemia as indicated by elevated serum P levels in patients receiving renal replacement therapy.
Salivary phosphate levels are elevated in patients with CKD and salivary P represents a large source of otherwise hidden non-dietary phosphate that is easily absorbed and may contribute to persistent elevations in serum P despite standard therapy.
Savica et al performed a preliminary study, in a small population (n-13) of hyperphosphatemic patients receiving hemodialysis, phosphate restriction and phosphate binders, and given K2CG chewing gum 20 mg. The chewing gum was administered twice per day for 60 minutes during fasting periods (between meals) for 15 days. In addition to a significant reduction in salivary P, serum P was reduced by 2 mg/dL (31%) over the treatment period. Both salivary and serum P returned to baseline values after K2CG discontinuation. The authors concluded that adding salivary P binding to traditional phosphate binders could be a useful approach for improving treatment of hyperphosphatemia in patients receiving renal replacement therapy (RRT).
Given the public health importance of increased P levels in the general population and specifically in patients with chronic kidney disease, it is of great importance to evaluate the ability of a medical food such as K2CG to reduce elevated serum P levels. In patients with CKD receiving RRT it has been estimated that sustained control of serum P may result in an approximate 17% reduction in mortality.
The specific purpose of this study is to compare the total P recovered per piece of chewing gum with 20 mg and 60 mg versions of the reformulated K2CG with or without the extender in the gum core. Additionally, the unique P binding of the reformulated gum will be assessed in comparison with the total P entrapped per piece of chewing gum in the matching placebos.
Subjects will be assigned to one of 3 different groups as shown in the table below. The study will be a single blind study. Subjects will be blinded as to the strength/formulation of the chewing gum and the active/placebo assignment.
Group Active Chewing Week 1 Active Chewing Week 2 20 mg with extender 20 mg Placebo 20 Placebo 60 60 mg with extender 60 mg
Subjects will chew the K2CG gum of a single strength/formulation for 7 days (Active Chewing Week 1) twice a day (BID). K2CG gum must be chewed at least 60 minutes in fasting conditions. This will be followed by a second 7 days of chewing K2CG gum (Active Chewing Week 2) of a different strength/formulation as described above.
There will be no run-in period and no wash out period between Active Chewing Week 1 and Active Chewing Week 2.
- Conditions
- Chronic Kidney Disease
- Being tested
- chewing gum
- Keywords
- chronic kidney disease, K2CG chewing gum, phosphorus, saliva
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chewing gumOther
single piece of chewing gum containing specified amount of chitosan with or without extender chewed twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo 20mg | Placebo comparator | Not described Receives: Other: chewing gum |
| K2CG 60 mg extender | Active comparator | Not described Receives: Other: chewing gum |
| K2CG 60 mg | Active comparator | Not described Receives: Other: chewing gum |
| K2CG 20mg extender | Active comparator | Not described Receives: Other: chewing gum |
| K2CG 20mg | Active comparator | Not described Receives: Other: chewing gum |
| Placebo 60mg | Placebo comparator | Not described Receives: Other: chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionApr 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 Chronic Kidney DiseaseStudies 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
- Early Phase 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Nephrologists, P.C.
- Sponsor type
- University, hospital or other
- Collaborators
- CM&D Pharma, LTD
- Investigators
- Geoffrey A Block, MD, Principal investigator, Denver Nephrologists, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341691
- Sponsor's protocol ID
- CMD 006
- Status last verified
- Apr 2011
- First submitted
- 23 Apr 2011
- Last updated
- 26 Apr 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 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2 Week Single Blind Study to Evaluate Phosphate Binding of Chitosan Chewing Gum in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01341691
- Acronym / sponsor ID
- CMD 006
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, K2CG chewing gum, phosphorus, saliva
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Denver Nephrologists, P.C.University, hospital or other
- Collaborators
- CM&D Pharma, LTD
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 26 Apr 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.
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.
Detailed description
The current treatment for elevated serum phosphorus levels in chronic kidney disease (CKD) consists of dietary restriction of P and the provision of phosphate binders that act at the level of the intestinal absorption of phosphorus (P) when ingested with meals. This paradigm has proven to be inadequate to achieve normo-phosphatemia as indicated by elevated serum P levels in patients receiving renal replacement therapy.
Salivary phosphate levels are elevated in patients with CKD and salivary P represents a large source of otherwise hidden non-dietary phosphate that is easily absorbed and may contribute to persistent elevations in serum P despite standard therapy.
Savica et al performed a preliminary study, in a small population (n-13) of hyperphosphatemic patients receiving hemodialysis, phosphate restriction and phosphate binders, and given K2CG chewing gum 20 mg. The chewing gum was administered twice per day for 60 minutes during fasting periods (between meals) for 15 days. In addition to a significant reduction in salivary P, serum P was reduced by 2 mg/dL (31%) over the treatment period. Both salivary and serum P returned to baseline values after K2CG discontinuation. The authors concluded that adding salivary P binding to traditional phosphate binders could be a useful approach for improving treatment of hyperphosphatemia in patients receiving renal replacement therapy (RRT).
Given the public health importance of increased P levels in the general population and specifically in patients with chronic kidney disease, it is of great importance to evaluate the ability of a medical food such as K2CG to reduce elevated serum P levels. In patients with CKD receiving RRT it has been estimated that sustained control of serum P may result in an approximate 17% reduction in mortality.
The specific purpose of this study is to compare the total P recovered per piece of chewing gum with 20 mg and 60 mg versions of the reformulated K2CG with or without the extender in the gum core. Additionally, the unique P binding of the reformulated gum will be assessed in comparison with the total P entrapped per piece of chewing gum in the matching placebos.
Subjects will be assigned to one of 3 different groups as shown in the table below. The study will be a single blind study. Subjects will be blinded as to the strength/formulation of the chewing gum and the active/placebo assignment.
Group Active Chewing Week 1 Active Chewing Week 2 20 mg with extender 20 mg Placebo 20 Placebo 60 60 mg with extender 60 mg
Subjects will chew the K2CG gum of a single strength/formulation for 7 days (Active Chewing Week 1) twice a day (BID). K2CG gum must be chewed at least 60 minutes in fasting conditions. This will be followed by a second 7 days of chewing K2CG gum (Active Chewing Week 2) of a different strength/formulation as described above.
There will be no run-in period and no wash out period between Active Chewing Week 1 and Active Chewing Week 2.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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;
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 |
|---|---|---|
| chewing gumsingle piece of chewing gum containing specified amount of chitosan with or without extender chewed twice daily for 14 days | Other | K2CG 20mg, K2CG 20mg extender, K2CG 60 mg, K2CG 60 mg extender, Placebo 20mg, Placebo 60mg |
Primary outcome
Total phosphorus bound and entrapped per piece of chewing gum
Time frame: 60 minutes
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.
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 26 Apr 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 Early Phase 1 study testing chewing gum in people with 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 6 inclusion and 5 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 26 Apr 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 phosphorus bound and entrapped per piece of chewing gum (time frame: 60 minutes). 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 NCT01341691, 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 26 Apr 2011.