Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 10/14/2017 |
| Start Date: | November 2005 |
| End Date: | July 2008 |
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.
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.
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:
1. 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.
2. 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.
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:
1. 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.
2. 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.
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
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