Status:
COMPLETED
Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry
Lead Sponsor:
Ege University
Collaborating Sponsors:
University of Kentucky
Fresenius Medical Care North America
Conditions:
End-Stage Renal Disease
Hemodialysis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 cardiovascula...
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%). Fo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
457 Patients enrolled
Trial Details
Trial ID
NCT00297219
Start Date
November 1 2005
End Date
July 1 2008
Last Update
August 4 2009
Active Locations (3)
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1
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536-0084
2
FMC Clinics
Bornova, İzmir, Turkey (Türkiye)
3
Ege University School of Medicine
Bornova-Izmir, Turkey (Türkiye), 35100