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OpenTrials
Completed

NCT Number: NCT02672293

Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phoslax

Drug

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

Other names: Sodium Phosphate

Primary outcomes

  1. 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

Secondary outcomes

  1. Fibroblast growth factor-23

    Time frame: Change in level of fibroblast growth factor 23 at 2 hours

    Biomarker of phosphate homeostasis

  2. Vitamin D

    Time frame: Change in level of vitamin D and vitamin D metabolites at 2 hours

    Biomarker of phosphate homeostasis

  3. klotho

    Time frame: Change in level of circulation kloth at 2 hours

    Biomarker of phosphate homeostasis

Sponsors and collaborators

Lead sponsor

Dr. Rachel Holden

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2016
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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