Summary

for people ages 21 years and up (full criteria)
study started
estimated completion:

Description

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.

Official Title

The Effects of Phosphate on Microvascular Function

Details

Project Background: Recent studies have suggested that increased serum phosphate and phosphate intake may acute impair microvascular blood flow. However, this has never been directly tested using imaging techniques that directly measure microvascular flow. The end-stage renal disease population on hemodialysis at the VA San Diego is an ideal population to evaluate this effect.

Project Question: Does reduction of serum phosphate through the use of a phosphate binder (lanthanum carbonate) increase microvascular blood flow in persons with ESRD? Project Methods: The investigators propose a 4 week, randomized, double-blinded, placebo controlled, single-center, crossover trial. Participants will have their microvascular function assessed at the baseline of the study using laser-Doppler flowmetry and nail-fold capillaroscopy. They will then be randomized to either lanthanum carbonate or placebo for 2 weeks. Microvascular measurements will be repeated at the end of the 2 week period. Participants will then cross-over to the other study arm. After 2 weeks in the other study arm, they will have microvascular measurements repeated and the trial will then be complete. The primary outcome of the study will be the % change in skin blood flow after heating from 31 degrees Celsius to 44 degrees Celsius. This will be compared within each individual after they complete each arm of the study. Changes seen on nail-fold capillaroscopy, acceptability, safety, and adherence will be key secondary outcomes.

Keywords

End Stage Renal Disease Hyperphosphatemia ESRD Microvascular LDF Kidney Failure, Chronic Withholding standard phosphate binder

Eligibility

You can join if…

Open to people ages 21 years and up

  • Diagnosis of ESRD on hemodialysis (HD) for >90 days.
  • Age >21.
  • Capacity to understand and sign informed consent as assess by principal investigator.
  • On a phosphate binder with stable dose for >2 weeks.
  • Serum phosphate at screening visit of <7.0.

You CAN'T join if...

  • Pregnancy.
  • Actively breastfeeding.
  • Use of oral contraceptives.
  • Inability to take oral medications.
  • History of medication non-compliance as assessed by the treating physician.
  • Patients currently enrolled in another trial.
  • Planned or expected surgical procedure during study period.
  • Planned or expected hospitalization during study period.
  • Corrected serum calcium greater than 10.2 mg/dl.
  • Serum intact PTH >1000 pg/ml
  • Albumin < 3 g/dl.
  • Allergy or intolerance to lanthanum carbonate.
  • Principal investigator deems patient to be unsuitable.
  • Non-English speaking persons. (Study performed at VA, therefore do not anticipate this represents a significant portion of the population).

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Veterans Medical Research Foundation
ID
NCT03594539
Study Type
Interventional
Last Updated
July 18, 2018