End-Stage Renal DiseaseNCT00297219
Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry
A study testing Low dialysate calcium and high dialysate calcium in people with End-Stage Renal Disease and Hemodialysis, run by Ege University at 3 sites in 2 countries.
Trial summary
The high rate of cardiovascular complications in the dialysis population cannot be explained by traditional cardiovascular risk factors. One of such factors proposed to contribute to the cardiovascular mortality in dialysis patient population is vascular calcification possibly resulting from disturbances of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-Stage Renal Disease, Hemodialysis
- What is being tested?
- Low dialysate calcium and high dialysate calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2005to Jul 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80 years
- On maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
- To be treated with a dialysate containing 1.75 or 1.5 mmol/L calcium
- Willingness to participate in the study with a written informed consent
Who cannot join
- To be scheduled for living donor renal transplantation
- To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
- Pregnancy or lactating
- To be unable to give informed consent because of mental incompetence or a psychiatric disorder
- To be on vitamin D treatment within six months of randomization or having iPTH values over target levels (>300 pg/mL)
- Hypercalcemia (Ca >10.5 mg/dl) with use of dialysate containing 1.75 or 1.5 mmol/L calcium
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Turkey (Türkiye)2 sites
FMC Clinics
Bornova, İzmir
Ege University School of Medicine
Bornova-Izmir, 35100
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0084
About this study
Official title: The Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry: Prospective, Randomized, Controlled Study
The high rate of cardiovascular complications in the dialysis population cannot be explained by traditional cardiovascular risk factors. One of such factors proposed to contribute to the cardiovascular mortality in dialysis patient population is vascular calcification possibly resulting from disturbances of calcium-phosphate metabolism.
The aim of this study is to assess the effects of treatment with dialysate containing 1.75 or 1.5 mmol/L to 1.25 mmol/L calcium regarding coronary artery calcification and bone histomorphometry in hemodialysis patients.
Read the detailed description
Sample size calculations were based on previously reported changes in coronary artery calcification scores in hemodialysis patients during time (90% power with a two-sided, alpha error rate of 5%). Four hundred fifty-seven hemodialysis patients, taking drop-out rate into consideration, will be enrolled in this prospective-controlled study.The cases already being treated with calcium-based phosphate binder and dialysate containing 1.75 or 1.5 mmol/L calcium will be enrolled from eight hemodialysis centers.The cases will be randomized to two arms:
- Dialysate containing 1.25 mmol/L calcium + calcium-based phosphate binder group: Dialysate calcium will be reduced from 1.75 or 1.5 mmol/L to 1.25 mmol/L in this group. Patients will use calcium-based phosphate binder according to phosphate level.
- Dialysate containing 1.75 mmol/L calcium + calcium-based phosphate binder group (Control group): Dialysate calcium will remain or switched to 1.75 mmol/L and patients will be on calcium-based phosphate binder.
The study will last for 18 months.Coronary artery calcification (Multi-slice CT), bone histomorphometry, and bone mineral density will be assessed in the beginning and at the end of the study. Coronary artery calcification and bone mineral density will be measured in all patients; bone histomorphometry will be assessed in 150 patients, 75 from each group.
- Conditions
- End-Stage Renal Disease, Hemodialysis
- Being tested
- Low dialysate calcium, high dialysate calcium
- Keywords
- Hemodialysis, Coronary artery calcification, Adynamic bone disease, Dialysate calcium, Bone mineral density, Bone histomorphometry
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dialysate calciumDrug
1.25 mmol/L dialysate calcium
high dialysate calciumDrug
1.75 mmol/L dialysate calcium
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | high dialysate calcium Receives: Drug: high dialysate calcium |
| 1 | Active comparator | low dialysate calcium Receives: Drug: Low dialysate calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of coronary artery calcification scores
Measured: eighteen months
Changes in bone histomorphometry analysis
Measured: eighteen months
Changes in bone mineral density
Measured: eighteen months
Secondary outcomes (2)
Changes in intact PTH levels
Measured: eighteen months
effects of dialysate with or without glucose (e.g intradialytic hypoglycemia and hypotension, arrythmia-by Holter ECG- and changes in HbA1c, insulin)
Measured: eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky, Fresenius Medical Care North America
- Investigators
- Ercan Ok, MD, Principal investigator, Ege University School of Medicine Nephrology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297219
- Sponsor's protocol ID
- EGE99803466003-2
- Other IDs
- MO1RR02602NCRR
- Status last verified
- Aug 2009
- First submitted
- 27 Feb 2006
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry: Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT00297219
- Acronym / sponsor ID
- EGE99803466003-2
- Conditions
- End-Stage Renal Disease, Hemodialysis
- Keywords
- Hemodialysis, Coronary artery calcification, Adynamic bone disease, Dialysate calcium, Bone mineral density, Bone histomorphometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- University of Kentucky, Fresenius Medical Care North America
- Study start
- Nov 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 28 Feb 2006 (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.
The high rate of cardiovascular complications in the dialysis population cannot be explained by traditional cardiovascular risk factors. One of such factors proposed to contribute to the cardiovascular mortality in dialysis patient population is vascular calcification possibly resulting from disturbances of calcium-phosphate metabolism.
The aim of this study is to assess the effects of treatment with dialysate containing 1.75 or 1.5 mmol/L to 1.25 mmol/L calcium regarding coronary artery calcification and bone histomorphometry in hemodialysis patients.
Detailed description
Sample size calculations were based on previously reported changes in coronary artery calcification scores in hemodialysis patients during time (90% power with a two-sided, alpha error rate of 5%). Four hundred fifty-seven hemodialysis patients, taking drop-out rate into consideration, will be enrolled in this prospective-controlled study.The cases already being treated with calcium-based phosphate binder and dialysate containing 1.75 or 1.5 mmol/L calcium will be enrolled from eight hemodialysis centers.The cases will be randomized to two arms:
- Dialysate containing 1.25 mmol/L calcium + calcium-based phosphate binder group: Dialysate calcium will be reduced from 1.75 or 1.5 mmol/L to 1.25 mmol/L in this group. Patients will use calcium-based phosphate binder according to phosphate level.
- Dialysate containing 1.75 mmol/L calcium + calcium-based phosphate binder group (Control group): Dialysate calcium will remain or switched to 1.75 mmol/L and patients will be on calcium-based phosphate binder.
The study will last for 18 months.Coronary artery calcification (Multi-slice CT), bone histomorphometry, and bone mineral density will be assessed in the beginning and at the end of the study. Coronary artery calcification and bone mineral density will be measured in all patients; bone histomorphometry will be assessed in 150 patients, 75 from each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: high dialysate calciumhigh dialysate calcium |
| 1 | Active comparator | Drug: Low dialysate calciumlow dialysate calcium |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 80 years
- On maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
- To be treated with a dialysate containing 1.75 or 1.5 mmol/L calcium
- Willingness to participate in the study with a written informed consent
Key exclusion criteria (6 listed)
- To be scheduled for living donor renal transplantation
- To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
- Pregnancy or lactating
- To be unable to give informed consent because of mental incompetence or a psychiatric disorder
- To be on vitamin D treatment within six months of randomization or having iPTH values over target levels (>300 pg/mL)
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 |
|---|---|---|
| Low dialysate calcium1.25 mmol/L dialysate calcium | Drug | 1 |
| high dialysate calcium1.75 mmol/L dialysate calcium | Drug | 2 |
Primary outcome
Progression of coronary artery calcification scores
Time frame: eighteen months
Changes in bone histomorphometry analysis
Time frame: eighteen months
Changes in bone mineral density
Time frame: eighteen months
2 secondary outcomes
Changes in intact PTH levels
Time frame: eighteen months
effects of dialysate with or without glucose (e.g intradialytic hypoglycemia and hypotension, arrythmia-by Holter ECG- and changes in HbA1c, insulin)
Time frame: eighteen months
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 4 Aug 2009.
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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.
Ercan Ok, MD principal investigator
Ege University School of Medicine Nephrology Department
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dialysate calcium and high dialysate calcium in people with End-Stage Renal Disease and Hemodialysis, run by Ege University at 3 sites in 2 countries.
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 4 inclusion and 6 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 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye), United States. 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?
Progression of coronary artery calcification scores (time frame: eighteen months). The study lists 3 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 4 Aug 2009.