Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry
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|ClinicalTrials.gov Identifier: NCT00297219|
Recruitment Status : Completed
First Posted : February 28, 2006
Last Update Posted : August 4, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|End-Stage Renal Disease Hemodialysis||Drug: Low dialysate calcium Drug: high dialysate calcium||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||457 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry: Prospective, Randomized, Controlled Study|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Active Comparator: 2
high dialysate calcium
Drug: high dialysate calcium
1.75 mmol/L dialysate calcium
Active Comparator: 1
low dialysate calcium
Drug: Low dialysate calcium
1.25 mmol/L dialysate calcium
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297219
|United States, Kentucky|
|University of Kentucky Medical Center|
|Lexington, Kentucky, United States, 40536-0084|
|Bornova, Izmir, Turkey|
|Ege University School of Medicine|
|Bornova-Izmir, Turkey, 35100|
|Principal Investigator:||Ercan Ok, MD||Ege University School of Medicine Nephrology Department|