Kidney DiseaseNCT00485706
Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients
A study testing high calcium dialysate in people with Kidney Disease and Hypercalcemia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Disease, Hypercalcemia
- What is being tested?
- high calcium dialysate
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteBelgium
- Study dates
- Jun 2007to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- maintenance hemodialysis patients
Who cannot join
- dialysis <3 months
- aortobifemoral graft
- calcium level predialysis >10.5 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
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"
- Conditions
- Kidney Disease, Hypercalcemia
- Being tested
- high calcium dialysate
- Keywords
- dialysis, vascular calcification, bone mineralism, arterial stiffness, bone metabolism, chronic kidney disease
- Medical subject headings
- Kidney Diseases, Hypercalcemia, Vascular Calcification, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high calcium dialysateProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 increase and vascular calcifications
correlation between calcium change and bone markers
correlation between calcium change and bone markers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- kathleen Claes, MD, Principal investigator, UZ Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485706
- Sponsor's protocol ID
- ML4181
- Other IDs
- S50455
- Status last verified
- Oct 2018
- First submitted
- 12 Jun 2007
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffness and Decreased Bone Buffering Capacity in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00485706
- Acronym / sponsor ID
- ML4181
- Conditions
- Kidney Disease, Hypercalcemia
- Keywords
- dialysis, vascular calcification, bone mineralism, arterial stiffness, bone metabolism, chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2007
- First posted
- 13 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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"
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- maintenance hemodialysis patients
Key exclusion criteria (3 listed)
- dialysis <3 months
- aortobifemoral graft
- calcium level predialysis >10.5 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high calcium dialysate | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
correlation between calcium increase and vascular calcifications
correlation between calcium change and bone markers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kathleen Claes, MD principal investigator
UZ Gasthuisberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high calcium dialysate in people with Kidney Disease and Hypercalcemia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between calcium increase and pulse wave velocity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.