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

August 3, 2009 updated by: Ege University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

457

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bornova-Izmir, Turkey, 35100
        • Ege University School of Medicine
    • Izmir
      • Bornova, Izmir, Turkey
        • FMC Clinics
  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0084
        • University of Kentucky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression of coronary artery calcification scores
Time Frame: eighteen months
eighteen months
Changes in bone histomorphometry analysis
Time Frame: eighteen months
eighteen months
Changes in bone mineral density
Time Frame: eighteen months
eighteen months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in intact PTH levels
Time Frame: eighteen months
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
eighteen months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Collaborators

University of Kentucky
Fresenius Medical Care North America

Investigators

  • Principal Investigator: Ercan Ok, MD, Ege University School of Medicine Nephrology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

February 27, 2006

First Submitted That Met QC Criteria

February 27, 2006

First Posted (Estimate)

February 28, 2006

Study Record Updates

Last Update Posted (Estimate)

August 4, 2009

Last Update Submitted That Met QC Criteria

August 3, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGE99803466003-2
  • MO1RR02602NCRR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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