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| ID | Type | Description | Link |
|---|---|---|---|
| MO1RR02602NCRR |
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| Name | Class |
|---|---|
| University of Kentucky | OTHER |
| Fresenius Medical Care North America | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | high dialysate calcium |
|
| 1 | Active Comparator | low dialysate calcium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dialysate calcium | Drug | 1.25 mmol/L dialysate calcium |
| |
| high dialysate calcium |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of coronary artery calcification scores | eighteen months | |
| Changes in bone histomorphometry analysis | eighteen months | |
| Changes in bone mineral density | eighteen months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in intact PTH levels | eighteen months | |
| effects of dialysate with or without glucose (e.g intradialytic hypoglycemia and hypotension, arrythmia-by Holter ECG- and changes in HbA1c, insulin) | eighteen months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ercan Ok, MD | Ege University School of Medicine Nephrology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Medical Center | Lexington | Kentucky | 40536-0084 | United States | ||
| FMC Clinics |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 4, 2015 | |
| Reset | Oct 30, 2015 |
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| Drug |
1.75 mmol/L dialysate calcium |
|
| Bornova |
| İzmir |
| Turkey (Türkiye) |
| Ege University School of Medicine | Bornova-Izmir | 35100 | Turkey (Türkiye) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 4, 2015 | Oct 30, 2015 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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