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

Hemodialysis Clinical Trial

Official title:

The Effects of Lowering Dialysate Calcium Level on Progression of Coronary Artery Calcification and Bone Histomorphometry: Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297219
• Other study ID #: EGE99803466003-2
• Secondary ID: MO1RR02602NCRR
• Status: Completed
• Phase: N/A
• First received: February 27, 2006
• Last updated: August 3, 2009
• Start date: November 2005
• Est. completion date: July 2008

Study information

• Verified date: August 2009
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Calcinosis
• Coronary Artery Disease
• End-Stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic

Intervention

Drug:
• Low dialysate calcium
1.25 mmol/L dialysate calcium
• high dialysate calcium
1.75 mmol/L dialysate calcium

Locations

Country	Name	City	State
Turkey	FMC Clinics	Bornova	Izmir
Turkey	Ege University School of Medicine	Bornova-Izmir
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Ege University	Fresenius Medical Care North America, University of Kentucky

Countries where clinical trial is conducted

United States,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of coronary artery calcification scores		eighteen months
Primary	Changes in bone histomorphometry analysis		eighteen months
Primary	Changes in bone mineral density		eighteen months
Secondary	Changes in intact PTH levels		eighteen months
Secondary	effects of dialysate with or without glucose (e.g intradialytic hypoglycemia and hypotension, arrythmia-by Holter ECG- and changes in HbA1c, insulin)		eighteen months