NCT02672293

Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate

Completed NA Last updated 29 June 2022

What this trial tests

NA trial testing Phoslax in Chronic Kidney Disease in 78 participants. Completed in 18 April 2018.

Timeline

1 January 2013

Primary endpoint
18 April 2018

18 April 2018

Quick facts

Lead sponsor	Dr. Rachel Holden
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	78
Start date	1 January 2013
Primary completion	18 April 2018
Estimated completion	18 April 2018
Sites	1 location across Canada

Drugs / interventions tested

• Phoslax — full drug profile →

Conditions studied

• Chronic Kidney Disease — all drugs for Chronic Kidney Disease →

Sponsor

Dr. Rachel Holden

Who can join

18 and older, any sex, with Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.