Haemodialysis patients suffer from many problems with blood vessels and this is even more so for patients with the added complication of diabetes. Diabetics have a number of reasons for vascular disease and one of the new areas of research is looking at the cells that line the blood vessels, called endothelial cells. It is thought that the number of red blood cells in the blood (haemoglobin concentration) affects the function of these cells. There is very little information available on what haemoglobin level is best for diabetic haemodialysis patients. As diabetics account for almost 40% of dialysis patients worldwide it is important to understand the effect different haemoglobin levels will have on the blood vessels.

Hypothesis: Endothelial cell function and the related expansile capacity of blood vessels are affected by different haemoglobin concentrations [Hb] in diabetic haemodialysis patients.

Condition	Intervention
Kidney Failure, Chronic Dialysis Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2	Procedure: Changing hemoglobin concentration

Further Study Details: 

Expected Total Enrollment:  15

This project is going to ask diabetic haemodialysis patients to undergo a series of tests at three different time points over a one year period: a baseline set of tests, tested when haemoglobin is maintained at 130-140g/L and repeat the tests when haemoglobin is maintained at 105-115g/L. The current recommendation for haemoglobin is 110-120g/L. Patients will not be required to take any study medication but a specialist kidney doctor, using their usual medications of iron and erythropoietin therapy, will change their haemoglobin levels.

Ages Eligible for Study:  20 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diabetics (Types I and II), on conventional haemodialysis 3-4 x week, for a duration of > 6 months
• Stable dialysis access for at least 3 months (permcath / PTFE / AVF)
• On erythropoietin and iron therapy, with stable [Hb] x 2 months (105 – 135g/L)

• On drug therapy which includes:

  • ACEii/ARB;

    • Statin >/- 10 mg or equivalent
  • ECASA 81 mg (at least 300 mg / wk)
  • (Note If patient not on drugs recently started and stable dose x 4 weeks)

Exclusion Criteria:

1. Uncontrolled BP: requiring dry weight or medication changes within 4 weeks prior to study
2. Pre dialysis SBP> 180 mmHg on > 2 times within a 2 week period
3. Between dialysis weight gain > 5% of body weight (if evident > 2 times/ 2 week period)
4. Soft tissue ulcers
5. Non traumatic amputations
6. Unstable cardiac function: ischaemic or non ischaemic events requiring modification of therapy, or admission to hospital within 3 months of study start: according to clinical discretion
7. Planned operative procedures within 6 months of study start (including Transplant, CABG, PTCA)
8. Dementia
9. Clinical inability to comply with testing
10. Malignancy (active / under treatment)
11. Known hypo-responsiveness to ERT (>200U/kg/wk)
12. Evidence of chronic gastrointestinal bleeding

Please refer to this study by ClinicalTrials.gov identifier  NCT00226902

Lawrence P McMahon, MD      61 3 9342 8353    lawrence.mcmahon@mh.org.au

Study chairs or principal investigators

Lawrence P McMahon, MD,  Principal Investigator,  Melbourne Health   

Study ID Numbers:  Interactedd
Last Updated:  September 26, 2005
Record first received:  September 26, 2005
ClinicalTrials.gov Identifier:  NCT00226902
Health Authority: Australia: Human Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-27