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Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate

Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02672293
Enrollment
78
Registered
2016-02-03
Start date
2013-01-31
Completion date
2018-04-18
Last updated
2022-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Brief summary

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.

Detailed description

Fractional excretion of phosphate will be measured pre- and 60 minutes and 120 minutes following an oral challenge of 500 mg of oral phosphate in a group of patients with gold standard measures of glomerular filtration rate.

Interventions

DRUGPhoslax

Oral sodium phosphate solution (monobasic sodium phosphate 2.4 g and dibasic sodium phosphate 0.9g / 5 mL).

Sponsors

Dr. Rachel Holden
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* stable chronic kidney disease

Exclusion criteria

* unable/unwilling to give informed consent; * pregnant or breast-feeding; * known allergy to shellfish, iodine or inulin; * have evidence of impaired bladder emptying defined as a post-void residual of greater than 20 ml.

Design outcomes

Primary

MeasureTime frameDescription
Fractional excretion of phosphateChange in fractional excretion of phosphate at 1 and 2 hoursFractional excretion of phosphate will be measured at baseline and at 1 and 2 hours following a standardized oral phosphate challenge

Secondary

MeasureTime frameDescription
Fibroblast growth factor-23Change in level of fibroblast growth factor 23 at 2 hoursBiomarker of phosphate homeostasis
Vitamin DChange in level of vitamin D and vitamin D metabolites at 2 hoursBiomarker of phosphate homeostasis
klothoChange in level of circulation kloth at 2 hoursBiomarker of phosphate homeostasis

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026