Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate
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|ClinicalTrials.gov Identifier: NCT02672293|
Recruitment Status : Unknown
Verified March 2018 by Dr. Rachel Holden, Queen's University.
Recruitment status was: Recruiting
First Posted : February 3, 2016
Last Update Posted : March 5, 2018
Over 20 million people in North America (including 2 million Canadians) have chronic kidney disease. These individuals die from diseases of the heart and blood vessels more often than they need dialysis. This is due to hardening of the arteries caused by calcium deposits inside the blood vessel walls. These deposits damage the vessels, causing them to lose flexibility. This makes them unable to respond to the changing demands of the body, and eventually leads to blockages such as stroke and ultimately death.
High levels of phosphate in the blood have been consistently linked to the development of calcium deposits inside blood vessel walls. The kidney is the only organ in the body that can eliminate phosphate that is not required by the body. As kidney function becomes worse, body levels of phosphate increase. However, investigators do not know the time point in the course of kidney disease that problems begin in the way phosphate is eliminated into the urine by the kidneys. Investigators will test the response of the kidneys to a phosphate challenge taken by mouth in subjects who are having accurate measures of kidney function performed by a method called 'inulin clearance'.
The investigators believe that the results of this study will provide important information identifying when investigators should be concerned about body levels of phosphate increasing. This information may lead to changes in the way investigators treat patients by reducing the levels of phosphate in the diet at a much earlier time point then is presently recommended.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Drug: Phoslax||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
500 mg of oral phosphate is administered after an overnight fast.
Oral sodium phosphate solution (monobasic sodium phosphate 2.4 g and dibasic sodium phosphate 0.9g / 5 mL).
Other Name: Sodium Phosphate
- Fractional excretion of phosphate [ Time Frame: Change in fractional excretion of phosphate at 1 and 2 hours ]Fractional excretion of phosphate will be measured at baseline and at 1 and 2 hours following a standardized oral phosphate challenge
- Fibroblast growth factor-23 [ Time Frame: Change in level of fibroblast growth factor 23 at 2 hours ]Biomarker of phosphate homeostasis
- Vitamin D [ Time Frame: Change in level of vitamin D and vitamin D metabolites at 2 hours ]Biomarker of phosphate homeostasis
- klotho [ Time Frame: Change in level of circulation kloth at 2 hours ]Biomarker of phosphate homeostasis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672293
|Contact: Rachel Holden, MDfirstname.lastname@example.org|
|Kingston General Hospital||Recruiting|
|Kingston, Ontario, Canada, K7L 3V6|
|Contact: Rachel M Holden, MD 613-533-3134 email@example.com|
|Principal Investigator: Rachel M Holden, MD|
|Principal Investigator: Christine A White, MD|
|Principal Investigator: Michael A Adams, PhD|
|Study Chair:||Rachel M Holden, MD||Queen's University|