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

This study has been completed.
Sponsor:
Collaborators:
University of Kentucky
Fresenius Medical Care North America
Information provided by:
Ege University
ClinicalTrials.gov Identifier:
NCT00297219
First received: February 27, 2006
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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
Hemodialysis
Drug: Low dialysate calcium
Drug: high dialysate calcium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Changes in bone histomorphometry analysis [ Time Frame: eighteen months ] [ Designated as safety issue: No ]
  • Changes in bone mineral density [ Time Frame: eighteen months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in intact PTH levels [ Time Frame: eighteen months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297219

Locations
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536-0084
Turkey
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
Investigators
Principal Investigator: Ercan Ok, MD Ege University School of Medicine Nephrology Department
  More Information

No publications provided

Responsible Party: Ege University
ClinicalTrials.gov Identifier: NCT00297219     History of Changes
Other Study ID Numbers: EGE99803466003-2, MO1RR02602NCRR
Study First Received: February 27, 2006
Last Updated: August 3, 2009
Health Authority: Turkey: Ministry of Health

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

Additional relevant MeSH terms:
Calcinosis
Kidney Diseases
Kidney Failure, Chronic
Coronary Artery Disease
Arteriosclerosis
Calcium Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Calcium, Dietary
Dialysis Solutions
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Pharmaceutical Solutions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014