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Sponsored by: |
University of British Columbia |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00175734 |
The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.
Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin concentrations in diabetic hemodialysis patients.
Condition | Intervention |
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Diabetes |
Procedure: High Hemoglobin Concentration Procedure: Low Hemoglobin Concentration |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study |
Official Title: | Integrated Studies in Vascular Reactivity and Anemia Correction Therapy in Endstage Kidney Disease Patients |
Estimated Enrollment: | 80 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Vascular disease is an important cause of morbidity and mortality in patients with chronic kidney disease (CKD), of which a large proportion is diabetic. Diabetics have complex and multiple reasons for vascular disease, and there is accumulating evidence of associated poor endothelial cell function, particularly in those with kidney disease. One important mechanism through which this might occur relates to changes in shear rate and stress resulting from different viscosity levels. Such fluctuations are increasingly recognized to affect endothelial cell function and hence vessel-wall adaptability in both the short and long term.
Little is known of the consequence of different shear effects on endothelial cell function at various hemoglobin levels in kidney disease. There is some evidence to suggest however that, in the presence of micro-vascular disease, a relative anemia, with associated lower viscosity and shear stress, may be of benefit compared to higher hemoglobin levels.
Diabetics account for almost 40% of dialysis patients worldwide, and are the fastest growing component of the epidemic of CKD. Thus, an understanding of optimal treatment targets for anemia therapy, and the impact of different target levels of hemoglobin on vascular wall function is imperative.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Katy Vela | 604-806-9460 ext 62510 | kvela@providencehealth.bc.ca |
Canada, British Columbia | |
St. Paul's Hospital | Recruiting |
Vancouver, British Columbia, Canada | |
Contact: Katy Vela 604-806-9460 ext 62510 kvela@providencehealth.bc.ca | |
Principal Investigator: Adeera Levin, MD |
Principal Investigator: | Adeera Levin | University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Adeera Levin ) |
Study ID Numbers: | P04-0007 |
Study First Received: | September 13, 2005 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00175734 |
Health Authority: | Canada: Health Canada |
Vascular Reactivity Anemia Correction Therapy Hemodialysis patients Diabetic and non-diabetic patients Diabetes in Hemodialysis patients |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Diabetes Mellitus |
Anemia Kidney Failure, Chronic Kidney Diseases Kidney Failure |