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

This study has been completed.
University of Kentucky
Fresenius Medical Care North America
Information provided by:
Ege University Identifier:
First received: February 27, 2006
Last updated: August 3, 2009
Last verified: August 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 Intervention
End-Stage Renal Disease
Drug: Low dialysate calcium
Drug: high dialysate calcium

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry: Prospective, Randomized, Controlled Study

Resource links provided by NLM:

Further study details as provided by Ege University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 457
Study Start Date: November 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00297219

United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536-0084
FMC Clinics
Bornova, Izmir, Turkey
Ege University School of Medicine
Bornova-Izmir, Turkey, 35100
Sponsors and Collaborators
Ege University
University of Kentucky
Fresenius Medical Care North America
Principal Investigator: Ercan Ok, MD Ege University School of Medicine Nephrology Department
  More Information

Responsible Party: Ege University Identifier: NCT00297219     History of Changes
Other Study ID Numbers: EGE99803466003-2
Study First Received: February 27, 2006
Last Updated: August 3, 2009

Keywords provided by Ege University:
Coronary artery calcification
Adynamic bone disease
Dialysate calcium
Bone mineral density
Bone histomorphometry

Additional relevant MeSH terms:
Kidney Failure, Chronic
Coronary Artery Disease
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Calcium, Dietary
Dialysis Solutions
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmaceutical Solutions processed this record on May 24, 2017