NCT00485706

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

First QC Date

June 12, 2007

Last Update Submit

October 15, 2018

Conditions

Kidney DiseaseHypercalcemia

Keywords

dialysisvascular calcificationbone mineralismarterial stiffnessbone metabolismchronic kidney disease

Outcome Measures

Primary Outcomes (2)

  • correlation between calcium increase and pulse wave velocity

    correlation between calcium increase and pulse wave velocity

  • correlation between calcium change and pth change

    correlation between calcium change and pth change

Secondary Outcomes (2)

  • correlation between calcium increase and vascular calcifications

  • correlation between calcium change and bone markers

Interventions

high calcium dialysatePROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • maintenance hemodialysis patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Kidney DiseasesHypercalcemiaVascular CalcificationRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte ImbalanceCalcinosisRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • kathleen Claes, MD

    UZ Gasthuisberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2007

First Posted

June 13, 2007

Study Start

June 1, 2007

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

BE(1)