Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ege University
• Collaborators: Fresenius Medical Care North America; University of Kentucky
• Treatments: Calcium; Calcium, Dietary; Dialysis Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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