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CompletedNCT00485706Updated Oct 17, 2018

Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients

An interventional study of high calcium dialysate in Kidney Disease and Hypercalcemia, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-17.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Renal patients have an increased risk for cardiovascular complications. There is also increased vascular calcification and bone metabolism is similarly abnormal in patients with chronic kidney disease.

In dialysis patients frequent episodes of hypercalcaemia occur. In a healthy bone structure those episodes of hypercalcemia are buffered by the bone. The absence of bone buffering capacity in dialysis patients can be a mechanism for vascular calcifications.

Read the detailed description

Study hypothesis.

Patient with a higher ∆ Calcium (Calcium post - Calcium pre) have a diminished bone buffering capacity indicative for adynamic bone disease compared with patients with smaller ∆ Calcium.

This may result in higher extraosseous calcification and higher pulse wave velocity

∆ PTH/∆ Calcium may reflect the sensitivity and density of the calcium receptors; this may reflect parathyroid "health"

02

Conditions studied

  • Kidney Disease
  • Hypercalcemia

Keywords

  • dialysis
  • vascular calcification
  • bone mineralism
  • arterial stiffness
  • bone metabolism
  • chronic kidney disease
03

In context

Kidney Diseases

3,842 studies on the registry are indexed under Kidney Diseases; 492 are open to participants now.

Browse Kidney Diseases studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 959 studies on the registry; 263 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • maintenance hemodialysis patients

Exclusion criteria

Exclusion Criteria:

  • dialysis \<3 months
  • aortobifemoral graft
  • calcium level predialysis >10.5 mg/dl
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)

Interventions

  • Procedurehigh calcium dialysate
06

What researchers measure

Primary outcomes

  1. correlation between calcium increase and pulse wave velocity

    correlation between calcium increase and pulse wave velocity

  2. correlation between calcium change and pth change

    correlation between calcium change and pth change

Secondary outcomes

  1. correlation between calcium increase and vascular calcifications

    correlation between calcium increase and vascular calcifications

  2. correlation between calcium change and bone markers

    correlation between calcium change and bone markers

07

Study locations

1 site
  • UZ Gasthuisberg
    Leuven, 3000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00485706
Responsible party
Sponsor
First posted
Jun 13, 2007
Start date
Jun 2007
Last update
Oct 17, 2018

Study contacts

kathleen Claes, MD
principal investigator · UZ Gasthuisberg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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