MedTrace Logo

Phosphate Microvascular Study

NCT03594539 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-08-24

No results posted yet for this study

Summary

Elevated phosphate concentrations in the blood have been associated with multiple negative health outcomes in patients with chronic kidney disease as well as in the general population. These negative outcomes include an increased risk of vascular complications like heart attack and stroke. While complications like heart attack and stroke reflect obstructive disease in large blood vessels, recent evidence suggests that elevated phosphate concentrations may first lead to disease in small blood vessels.

This single site clinical trial will randomize 20 veterans with end stage renal disease on hemodialysis to either a phosphate binder or placebo and evaluated for changes in their microvascular function using laser-Doppler flowmtery and nail-fold capillaroscopy.

Conditions

Interventions

OTHER

Withholding standard phosphate binder

In this trial, placebo represents the intervention and not the control. Standard therapy for hyperphosphatemia in end-stage renal disease includes treatment with a phosphate binder. In this trial the intervention will be to withhold the phosphate binder and use placebo instead. In this way the effect of a higher serum phosphate can be evaluated.

Sponsors & Collaborators

  • San Diego Veterans Healthcare System

    collaborator FED

  • Veterans Medical Research Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-01-01
Completion
2021-07-17

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03594539 on ClinicalTrials.gov