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CompletedNCT00226902Updated May 5, 2015

Vascular Reactivity in Kidney Disease Patients

An interventional study of Changing hemoglobin concentration in Kidney Failure, Chronic, Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Melbourne Health. Completed at 1 site in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-05-05.

Sponsored by Melbourne Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Dialysis 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 dialysis 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 dialysis patients.

Read the detailed description

This project is going to ask dialysis patients (both diabetic and non-diabetic) 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.

02

Conditions studied

  • Kidney Failure, Chronic
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2

Keywords

  • Diabetes
  • Hemoglobin
  • Dialysis
  • Vascular reactivity
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 15 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Melbourne Health is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 18-80 years
  2. Patients receiving either conventional haemodialysis 3-4 x week, for a duration of > 6 months or peritoneal dialysis for a duration >6 months
  3. Stable dialysis access for at least 3 months (Permcath / PTFE / AVF)
  4. On erythropoietin and iron therapy, with stable [Hb] x 2 months (105 - 135g/L)

Exclusion criteria

Exclusion Criteria:

  1. Uncontrolled BP: requiring dry weight or medication changes within 4 weeks prior to study
  2. Patients with dysrhythmias
  3. Pre dialysis SBP> 180 mmHg on > 2 times within a 2 week period
  4. Between dialysis weight gain > 5% of body weight (if evident > 2 times/ 2 week period)
  5. Soft tissue ulcers
  6. Non traumatic amputations
  7. 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
  8. Planned operative procedures within 6 months of study start (including Transplant, CABG, PTCA, vascular surgery)
  9. Dementia
  10. Clinical inability to comply with testing
  11. Malignancy (active / under treatment)
  12. Known hypo-responsiveness to ERT (>200U/kg/wk)
  13. Evidence of chronic gastrointestinal bleeding
  14. Inadequate dialysis (PRU \< 65% or KT/V \< 1.2)
  15. Participation in investigational study within last 3 months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants

Interventions

  • ProcedureChanging hemoglobin concentration
06

What researchers measure

Primary outcomes

  1. Change in pulse wave velocity at the three different haemoglobin levels

07

Study locations

1 site
  • The Royal Melbourne Hospital
    Melbourne, Victoria 3050, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00226902
Lead sponsor
Melbourne Health
First posted
Sep 27, 2005
Start date
Sep 2006
Primary completion
Aug 2013
Completion
Sep 2013
Last update
May 5, 2015

Study contacts

Lawrence P McMahon, MD
principal investigator · Melbourne Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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