NCT01311973

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 22, 2011

Status Verified

March 1, 2011

Enrollment Period

4 months

First QC Date

March 3, 2011

Last Update Submit

July 21, 2011

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease, phosphorus, salivary phosphorus

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    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)

    single AM measurement between 7-11 am

  • Correlation between fasting salivary phosphorus and serum 1,25 vitamin D levels.

    single AM measurement between 7-11 am

  • Correlation between fasting salivary phosphorus and serum intact parathyroid hormone (iPTH) levels.

    single AM measurement between 7-11 am

Study Arms (7)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal healthy population an individuals with chronic kidney disease not on dialysis

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Nephrologists, PC

Denver, Colorado, 80230, United States

Location

Related Publications (1)

  • 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.

    PMID: 23797006DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine, and saliva

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Geoffrey A Block, MD

    Denver Nephrologists, PC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 10, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 22, 2011

Record last verified: 2011-03

Locations

US(1)