Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Phoslax

• Registration Number: NCT02672293
• Lead Sponsor: Dr. Rachel Holden

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-03
• Primary Completion: 2018-04-18
• Study Completion: 2018-04-18
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phosphate	Phoslax	500 mg of oral phosphate is administered after an overnight fast.

Primary Outcome Measures

Name	Time	Method
Fractional excretion of phosphate	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 Outcome Measures

Name	Time	Method
Fibroblast growth factor-23	Change in level of fibroblast growth factor 23 at 2 hours	Biomarker of phosphate homeostasis
Vitamin D	Change in level of vitamin D and vitamin D metabolites at 2 hours	Biomarker of phosphate homeostasis
klotho	Change in level of circulation kloth at 2 hours	Biomarker of phosphate homeostasis

Trial Locations

Locations (1)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada