Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry
Completed · Not applicable
Conditions studied: End-Stage Renal Disease, Hemodialysis
In brief
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.
Key facts
- Study ID
- NCT00297219
- Run by
- Ege University
- People needed
- 457
- Starts
- 2005-11-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2009-08-04
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Kentucky Medical Center — Lexington, Kentucky, United States
- FMC Clinics — Bornova, İzmir, Turkey (Türkiye)
- Ege University School of Medicine — Bornova-Izmir, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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