Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate

Chronic Kidney Disease Clinical Trial

Official title:

Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672293
• Other study ID #: Holden/White
• Secondary ID: Queen's Universi
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: April 18, 2018

Study information

• Verified date: June 2022
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Rachel Holden

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional excretion of phosphate	Fractional excretion of phosphate will be measured at baseline and at 1 and 2 hours following a standardized oral phosphate challenge	Change in fractional excretion of phosphate at 1 and 2 hours
Secondary	Fibroblast growth factor-23	Biomarker of phosphate homeostasis	Change in level of fibroblast growth factor 23 at 2 hours
Secondary	Vitamin D	Biomarker of phosphate homeostasis	Change in level of vitamin D and vitamin D metabolites at 2 hours
Secondary	klotho	Biomarker of phosphate homeostasis	Change in level of circulation kloth at 2 hours