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Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Phoslax
Sponsored by
Dr. Rachel Holden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kingston General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phosphate

Arm Description

500 mg of oral phosphate is administered after an overnight fast.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fibroblast growth factor-23
Biomarker of phosphate homeostasis
Vitamin D
Biomarker of phosphate homeostasis
klotho
Biomarker of phosphate homeostasis

Full Information

First Posted
January 16, 2013
Last Updated
June 29, 2022
Sponsor
Dr. Rachel Holden
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1. Study Identification

Unique Protocol Identification Number
NCT02672293
Brief Title
Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate
Official Title
Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Rachel Holden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phosphate
Arm Type
Experimental
Arm Description
500 mg of oral phosphate is administered after an overnight fast.
Intervention Type
Drug
Intervention Name(s)
Phoslax
Other Intervention Name(s)
Sodium Phosphate
Intervention Description
Oral sodium phosphate solution (monobasic sodium phosphate 2.4 g and dibasic sodium phosphate 0.9g / 5 mL).
Primary Outcome Measure Information:
Title
Fractional excretion of phosphate
Description
Fractional excretion of phosphate will be measured at baseline and at 1 and 2 hours following a standardized oral phosphate challenge
Time Frame
Change in fractional excretion of phosphate at 1 and 2 hours
Secondary Outcome Measure Information:
Title
Fibroblast growth factor-23
Description
Biomarker of phosphate homeostasis
Time Frame
Change in level of fibroblast growth factor 23 at 2 hours
Title
Vitamin D
Description
Biomarker of phosphate homeostasis
Time Frame
Change in level of vitamin D and vitamin D metabolites at 2 hours
Title
klotho
Description
Biomarker of phosphate homeostasis
Time Frame
Change in level of circulation kloth at 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel M Holden, MD
Organizational Affiliation
Queen's University
Official's Role
Study Chair
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Determining Oral Phosphate Tolerance Across the Spectrum of Glomerular Filtration Rate

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