NCT00297219

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
457

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

2.7 years

First QC Date

February 27, 2006

Last Update Submit

August 3, 2009

Conditions

End-Stage Renal DiseaseHemodialysis

Keywords

HemodialysisCoronary artery calcificationAdynamic bone diseaseDialysate calciumBone mineral densityBone histomorphometry

Outcome Measures

Primary Outcomes (3)

  • Progression of coronary artery calcification scores

    eighteen months

  • Changes in bone histomorphometry analysis

    eighteen months

  • Changes in bone mineral density

    eighteen months

Secondary Outcomes (2)

  • 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

Study Arms (2)

2

ACTIVE COMPARATOR

high dialysate calcium

Drug: high dialysate calcium

1

ACTIVE COMPARATOR

low dialysate calcium

Drug: Low dialysate calcium

Interventions

Low dialysate calciumDRUG

1.25 mmol/L dialysate calcium

1
high dialysate calciumDRUG

1.75 mmol/L dialysate calcium

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Kentucky Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

FMC Clinics

Bornova, İzmir, Turkey (Türkiye)

Location

Ege University School of Medicine

Bornova-Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ercan Ok, MD

    Ege University School of Medicine Nephrology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2006

First Posted

February 28, 2006

Study Start

November 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations

TU(2)US(1)