HyperphosphatemiaPhase 1NCT01057108
Double Blind Randomized Placebo Controlled Trial of FOSTRAP Chewing Gum in Patients With CKD and Hyperphosphatemia
A Phase 1 study testing FOSTRAP 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 phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce serum levels of phosphorus in patients with chronic kidney disease. 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?
- FOSTRAP Chewing Gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2010
- Phase
- 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;
- For subjects with CKD not on dialysis- kidney function at any stage that in the opinion of the investigator is stable and not expected to initiate dialysis within 3 months;
- For subjects with CKD not on dialysis- a screening serum phosphorus value greater than or equal to 4.5 mg/dL;
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- For subjects with ESRD - a screening serum phosphorus value greater than or equal to 4.6 mg/dL and less than or equal to 9.0 mg/dL and one of the two conditions: A mean historical value of the most recent 2 phosphorus measurements ≥ 4.6 and less than or equal to 9.0 mg/dL at the time of written informed consent or A second screening serum phosphorus value greater than or equal to 4.6 mg/dL and less than or equal to 9.0 mg/dL performed not less than 7 days from the date of the previous screening;
- In the opinion of the investigator, subjects with ESRD must be prescribed a stable dialysis regimen (3x/week) for ≥ 4 weeks prior to baseline and must have a stable dialysis access;
- Subjects with ESRD must have an historical URR ≥ 65% for at least 4 weeks prior to baseline;
- All subjects must have NO change in prescribed dose or frequency of any of the following medications ≥ 14 days prior to baseline:
- Phosphate binding products including prescribed and over-the counter
- Oral or injectable active vitamin D
- Oral nutritional vitamin D
- Calcimimetics
- Calcium supplements
- Anti-osteoporotic medication (e.g. bisphosphonates)
- Subject must be prescribed a diet appropriate for patients with their stage of kidney disease, and must be willing to avoid intentional changes in diet; and
- Subjects must have a screening salivary flow rate by Saxon test ≥ 1 g/2 min.
Who cannot join
- Receiving or has received an investigational product (or is currently using an investigational device) within 28 days prior to baseline;
- Known sensitivity to chitin or allergy to shellfish;
- Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin;
- Clinically significant infection requiring treatment with antibiotics (within 7 days prior to baseline);
- Inpatient hospitalization within 14 days prior to baseline with the exception of hospitalizations related to vascular access procedures;
- Planned surgical intervention for secondary hyperparathyroidism;
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- In the opinion of the investigator, inability to chew gum for 60 minutes;
- Planned relocation to another area within the next 4 months;
- Subject has a known history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result;
- Active drug or alcohol dependence or abuse (excluding tobacco use) in the opinion of the principal investigator;
- Unstable medical condition which in the opinion of the investigator would compromise successful completion of the study;
- Known active liver disease with AST or ALT levels greater than 3X the upper limit of normal; and
- Subject has had a major cardiovascular event within 90 days of screening. The investigator should be guided by evidence of any of the following;
- Acute myocardial infarction
- Acute cerebral vascular event
- Vascular surgical intervention
- Coronary Revascularization
- Decompensated congestive heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Placebo Controlled Trial to Evaluate the Efficacy and Safety of FOSTRAP Chewing Gum in Patients With Chronic Kidney Disease and Hyperphosphatemia.
The phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce serum levels of phosphorus in patients with chronic kidney disease. We are testing this hypothesis using a chewing gum called FOSTRAP which has been shown to be effective in a small, non-randomized study in patients with chronic kidney disease on hemodialysis.
Read the detailed description
A double-blind, randomized, placebo, controlled trial with an open label extension for those subjects with end stage renal disease (ESRD).
Patients with ESRD will be randomized to receive either FOSTRAP™ 20 mg BID, FOSTRAP™ 40 mg BID or matching placebo 2x/day. All subjects will participate in a 4 week chewing period followed by a 4 week follow up period. All subjects will then enter an open label 2 week extension phase in which they will receive FOSTRAP™ 20 mg TID.
Patients with chronic kidney disease (CKD) not on dialysis will receive either FOSTRAP™ 20 mg 3x/day or placebo TID for 4 weeks followed by a 4 week follow up period.
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Being tested
- FOSTRAP Chewing Gum, Placebo chewing gum
- Keywords
- Hyperphosphatemia, chronic kidney disease, salivary phosphorus
- 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.
FOSTRAP Chewing GumOther
20 mg BID
FOSTRAP Chewing GumOther
40 mg BID
FOSTRAP Chewing GumOther
20 mg TID
FOSTRAP Chewing GumOther
20 mg TID
Placebo chewing gumOther
| Study group | Role | What they receive |
|---|---|---|
| ESRD: FOSTRAP Chewing Gum | Active comparator | Not described Receives: Other: FOSTRAP Chewing Gum |
| CKD: FOSTRAP Chewing Gum | Active comparator | Not described Receives: Other: FOSTRAP Chewing Gum |
| ESRD Matching Placebo | Placebo comparator | Not described Receives: Other: Placebo chewing gum |
| CKD Matching Placebo | Placebo comparator | Not described Receives: Other: Placebo chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum phosphorus from baseline to Day 29
Measured: Day 1 and Day 29
Secondary outcomes (6)
Change in salivary phosphorus from baseline to Day 29
Measured: Day and Day 29
Proportion of subjects whose serum phosphorus reduction from baseline to Day 29 is greater than or equal to 0.5 mg/dL
Measured: Day 1 and Day 29
Proportion of subjects whose serum phosphorus reduction from baseline to Day 29 is greater than or equal to 1.5 mg/dL
Measured: Day 1 and Day 29
Change in serum phosphorus from Day 57 to day 71 for subjects with ESRD
Measured: Day 57 and Day 71
For subjects with ESRD absolute and relative difference between serum phosphorus (baseline to Day 29)- (Day 57 to day 71)
Measured: Day 29, Day 57, Day 71
Change in salivary phosphorus from Day 57 to Day 71
Measured: Day 57 and Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
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
- NCT01057108
- Sponsor's protocol ID
- CMD 002
- Status last verified
- Jan 2011
- First submitted
- 25 Jan 2010
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086Block 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 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo Controlled Trial to Evaluate the Efficacy and Safety of FOSTRAP Chewing Gum in Patients With Chronic Kidney Disease and Hyperphosphatemia.
- ClinicalTrials.gov ID
- NCT01057108
- Acronym / sponsor ID
- CMD 002
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Keywords
- Hyperphosphatemia, chronic kidney disease, salivary phosphorus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Denver Nephrologists, P.C.University, hospital or other
- Collaborators
- CM&D Pharma Limited
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Jan 2010 (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 phosphorus content in saliva is increased in chronic kidney disease. We hypothesize that a chewing gum that binds salivary phosphorus would be a novel, effective agent to reduce serum levels of phosphorus in patients with chronic kidney disease. We are testing this hypothesis using a chewing gum called FOSTRAP which has been shown to be effective in a small, non-randomized study in patients with chronic kidney disease on hemodialysis.
Detailed description
A double-blind, randomized, placebo, controlled trial with an open label extension for those subjects with end stage renal disease (ESRD).
Patients with ESRD will be randomized to receive either FOSTRAP™ 20 mg BID, FOSTRAP™ 40 mg BID or matching placebo 2x/day. All subjects will participate in a 4 week chewing period followed by a 4 week follow up period. All subjects will then enter an open label 2 week extension phase in which they will receive FOSTRAP™ 20 mg TID.
Patients with chronic kidney disease (CKD) not on dialysis will receive either FOSTRAP™ 20 mg 3x/day or placebo TID for 4 weeks followed by a 4 week follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ESRD: FOSTRAP Chewing Gum | Active comparator | Other: FOSTRAP Chewing Gum |
| CKD: FOSTRAP Chewing Gum | Active comparator | Other: FOSTRAP Chewing Gum |
| ESRD Matching Placebo | Placebo comparator | Other: Placebo chewing gum |
| CKD Matching Placebo | Placebo comparator | Other: Placebo chewing gum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 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;
- For subjects with CKD not on dialysis- kidney function at any stage that in the opinion of the investigator is stable and not expected to initiate dialysis within 3 months;
Key exclusion criteria (18 listed)
- Receiving or has received an investigational product (or is currently using an investigational device) within 28 days prior to baseline;
- Known sensitivity to chitin or allergy to shellfish;
- Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin;
- Clinically significant infection requiring treatment with antibiotics (within 7 days prior to baseline);
- Inpatient hospitalization within 14 days prior to baseline with the exception of hospitalizations related to vascular access procedures;
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 |
|---|---|---|
| FOSTRAP Chewing Gum20 mg BID | Other | ESRD: FOSTRAP Chewing Gum |
| FOSTRAP Chewing Gum40 mg BID | Other | ESRD: FOSTRAP Chewing Gum |
| FOSTRAP Chewing Gum20 mg TID | Other | CKD: FOSTRAP Chewing Gum |
| FOSTRAP Chewing Gum20 mg TID | Other | ESRD: FOSTRAP Chewing Gum |
| Placebo chewing gum | Other | CKD Matching Placebo, ESRD Matching Placebo |
Primary outcome
Change in serum phosphorus from baseline to Day 29
Time frame: Day 1 and Day 29
6 secondary outcomes
Change in salivary phosphorus from baseline to Day 29
Time frame: Day and Day 29
Proportion of subjects whose serum phosphorus reduction from baseline to Day 29 is greater than or equal to 0.5 mg/dL
Time frame: Day 1 and Day 29
Proportion of subjects whose serum phosphorus reduction from baseline to Day 29 is greater than or equal to 1.5 mg/dL
Time frame: Day 1 and Day 29
Change in serum phosphorus from Day 57 to day 71 for subjects with ESRD
Time frame: Day 57 and Day 71
For subjects with ESRD absolute and relative difference between serum phosphorus (baseline to Day 29)- (Day 57 to day 71)
Time frame: Day 29, Day 57, Day 71
Change in salivary phosphorus from Day 57 to Day 71
Time frame: Day 57 and Day 71
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 7 Jan 2011.
- Derived from this study: PubMed 40576086Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
- 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 Phase 1 study testing FOSTRAP 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 18 inclusion and 18 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 7 Jan 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in serum phosphorus from baseline to Day 29 (time frame: Day 1 and Day 29). 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 NCT01057108, which also lists 2 linked publications.
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 7 Jan 2011.