Chronic Kidney DiseaseNCT01311973
Salivary Phosphorus and Level of Kidney Function
An observational study of 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 relationship between salivary phosphorus and kidney function, specifically as it relates to serum phosphorus, FGF23, PTH, vitamin D status and urinary excretion of phosphorus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2011
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal healthy population an individuals with chronic kidney disease not on dialysis
Who may be able to join
- Men or women greater than 18 years of age.
- The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB).
Who cannot join
- Receiving hemodialysis.
- Receiving or has received an investigational product (or is currently using an investigational device) within 28 days prior to Visit 2.
- Evidence of active and clinically significant infection at Visit 2.
- Dental work within 48 hours prior to Visit 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Relationship Between Salivary Phosphorus and Level of Kidney Function
The specific purpose of this study is to describe the relationship between salivary phosphorus and kidney function, specifically as it relates to serum phosphorus, FGF23, PTH, vitamin D status and urinary excretion of phosphorus.
Read the detailed description
Previous studies have demonstrated that salivary phosphate levels are elevated in patients with chronic kidney disease and that there is a direct and linear correlation between serum phosphorus and salivary phosphorus. However, data regarding the relationship between salivary phosphate levels and stage of kidney disease (estimated glomerular filtration rate (eGFR) is lacking; as such, this study seeks to examine that relationship.
There is a normal circadian rhythm to serum phosphorus with a mid-afternoon peak at approximately 3 PM and a nadir at approximately 7-11 AM. Furthermore it has been demonstrated that a fasting serum phosphorus level at 8 AM is NOT indicative of 24 hour mean serum phosphorus. Thus the relationship between salivary phosphorous and serum phosphorus may vary over the course of the day.
This is a single-center study in which saliva, urine, and serum will be collected at two time points in a minimum of 105 subjects with various degrees of renal function (not on dialysis). Assignment to the renal group will be based upon the Visit 2 estimated glomerular filtration rate value. Enrollment in each group will continue at random until the target of 15 subjects per group is achieved. It is possible that an individual group may exceed the target enrollment number as their assignment will occur retrospectively.
All subjects will be required to have their morning assessment conducted between the hours of 7AM and 11AM. Clinical chemistry, serum phosphorus, intact parathyroid hormone(iPTH), plasma fibroblast growth factor 23 (FGF-23),serum 1,25 di-hydroxyvitamin D, serum 25-OH vitamin D, and a spot urine will be collected. A 24-hour urine sample will also be collected.
Passive and stimulated salivary collection will occur. The salivary collection must occur in a fasting state with nothing to eat or drink for at least 90 minutes prior to the collection.
Subjects will be permitted to leave the facility. They will be instructed to consume a lunch of their choice between the hours of 1100AM and 1200PM. They will be instructed to eat nothing after 1200PM. Subjects will return to the clinic for Visit 3 as directed by the study staff. Visit 3 will be conducted between 1PM and 4PM. Laboratory assessments, salivary collections, and spot urines will be collected at Visit 3. A dietary recall of intake at Visit 2 and 3 will also be completed.
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, phosphorus, salivary phosphorus
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Renal Function Group #1 | Creatinine clearance > 90 mL/min | |
| Renal Function Group #2 | Creatinine clearance 60-69 mL/min | |
| Renal Function Group #3 | Creatinine clearance 50-59 mL/min | |
| Renal Function Group #4 | Creatinine clearance 40-49 mL/min | |
| Renal Function Group #5 | Creatinine clearance 30-39 mL/min | |
| Renal Function Group #6 | Creatinine clearance 20-29 mL/min | |
| Renal Function Group #7 | Creatinine clearance < 20 mL/min (not on dialysis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between fasting salivary phosphorus and estimated glomerular filtration rate
subjects with various levels of estimated glomerular filtration rate will have a single assessment in the fasted state of salivary phosphorus
Measured: single value between 7-11 am
Correlation between post meal salivary phosphorus and estimated glomerular filtration rate
subjects with various levels of estimated glomerular filtration rate will have a single assessment in the fed state (meal between 11 am - 12 noon) of salivary phosphorus measured between 1-4 pm
Measured: single value after meal between 1-4 pm
Secondary outcomes (3)
correlation of fasting salivary phosphorus with plasma fibroblast growth factor 23 levels(FGF-23)
subjects will have plasma FGF23 measured in the fasting state between 7-11 am and correlation made with simultaneous assessment of salivary phosphorus
Measured: single AM measurement between 7-11 am
Correlation between fasting salivary phosphorus and serum 1,25 vitamin D levels.
subjects will have serum 1,25 vitamin D measured in the fasting state between 7-11 am and correlation made with simultaneous assessment of salivary phosphorus
Measured: single AM measurement between 7-11 am
Correlation between fasting salivary phosphorus and serum intact parathyroid hormone (iPTH) levels.
subjects will have serum intact parathyroid hormone measured in the fasting state between 7-11 am and correlation made with simultaneous assessment of salivary phosphorus
Measured: single AM measurement between 7-11 am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 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
- NCT01311973
- Sponsor's protocol ID
- CMD 003
- Status last verified
- Mar 2011
- First submitted
- 3 Mar 2011
- Last updated
- 22 Jul 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 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relationship Between Salivary Phosphorus and Level of Kidney Function
- ClinicalTrials.gov ID
- NCT01311973
- Acronym / sponsor ID
- CMD 003
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, phosphorus, salivary phosphorus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Denver Nephrologists, P.C.University, hospital or other
- Collaborators
- CM&D Pharma Limited
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 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 relationship between salivary phosphorus and kidney function, specifically as it relates to serum phosphorus, FGF23, PTH, vitamin D status and urinary excretion of phosphorus.
Detailed description
Previous studies have demonstrated that salivary phosphate levels are elevated in patients with chronic kidney disease and that there is a direct and linear correlation between serum phosphorus and salivary phosphorus. However, data regarding the relationship between salivary phosphate levels and stage of kidney disease (estimated glomerular filtration rate (eGFR) is lacking; as such, this study seeks to examine that relationship.
There is a normal circadian rhythm to serum phosphorus with a mid-afternoon peak at approximately 3 PM and a nadir at approximately 7-11 AM. Furthermore it has been demonstrated that a fasting serum phosphorus level at 8 AM is NOT indicative of 24 hour mean serum phosphorus. Thus the relationship between salivary phosphorous and serum phosphorus may vary over the course of the day.
This is a single-center study in which saliva, urine, and serum will be collected at two time points in a minimum of 105 subjects with various degrees of renal function (not on dialysis). Assignment to the renal group will be based upon the Visit 2 estimated glomerular filtration rate value. Enrollment in each group will continue at random until the target of 15 subjects per group is achieved. It is possible that an individual group may exceed the target enrollment number as their assignment will occur retrospectively.
All subjects will be required to have their morning assessment conducted between the hours of 7AM and 11AM. Clinical chemistry, serum phosphorus, intact parathyroid hormone(iPTH), plasma fibroblast growth factor 23 (FGF-23),serum 1,25 di-hydroxyvitamin D, serum 25-OH vitamin D, and a spot urine will be collected. A 24-hour urine sample will also be collected.
Passive and stimulated salivary collection will occur. The salivary collection must occur in a fasting state with nothing to eat or drink for at least 90 minutes prior to the collection.
Subjects will be permitted to leave the facility. They will be instructed to consume a lunch of their choice between the hours of 1100AM and 1200PM. They will be instructed to eat nothing after 1200PM. Subjects will return to the clinic for Visit 3 as directed by the study staff. Visit 3 will be conducted between 1PM and 4PM. Laboratory assessments, salivary collections, and spot urines will be collected at Visit 3. A dietary recall of intake at Visit 2 and 3 will also be completed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Renal Function Group #1 | – | –Creatinine clearance > 90 mL/min |
| Renal Function Group #2 | – | –Creatinine clearance 60-69 mL/min |
| Renal Function Group #3 | – | –Creatinine clearance 50-59 mL/min |
| Renal Function Group #4 | – | –Creatinine clearance 40-49 mL/min |
| Renal Function Group #5 | – | –Creatinine clearance 30-39 mL/min |
| Renal Function Group #6 | – | –Creatinine clearance 20-29 mL/min |
| Renal Function Group #7 | – | –Creatinine clearance < 20 mL/min (not on dialysis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal healthy population an individuals with chronic kidney disease not on dialysis
Key inclusion criteria (2 listed)
- Men or women greater than 18 years of age.
- The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB).
Key exclusion criteria (4 listed)
- Receiving hemodialysis.
- Receiving or has received an investigational product (or is currently using an investigational device) within 28 days prior to Visit 2.
- Evidence of active and clinically significant infection at Visit 2.
- Dental work within 48 hours prior to Visit 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between fasting salivary phosphorus and estimated glomerular filtration rate
Time frame: single value between 7-11 am
subjects with various levels of estimated glomerular filtration rate will have a single assessment in the fasted state of salivary phosphorus
Correlation between post meal salivary phosphorus and estimated glomerular filtration rate
Time frame: single value after meal between 1-4 pm
subjects with various levels of estimated glomerular filtration rate will have a single assessment in the fed state (meal between 11 am - 12 noon) of salivary phosphorus measured between 1-4 pm
3 secondary outcomes
correlation of fasting salivary phosphorus with plasma fibroblast growth factor 23 levels(FGF-23)
Time frame: single AM measurement between 7-11 am
Correlation between fasting salivary phosphorus and serum 1,25 vitamin D levels.
Time frame: single AM measurement between 7-11 am
Correlation between fasting salivary phosphorus and serum intact parathyroid hormone (iPTH) levels.
Time frame: single AM measurement between 7-11 am
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 22 Jul 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?
An observational study of 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 2 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 22 Jul 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. 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?
Correlation between fasting salivary phosphorus and estimated glomerular filtration rate (time frame: single value between 7-11 am). 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 NCT01311973, 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 22 Jul 2011.