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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Vascular Reactivity in Kidney Disease Patients
Scientific title
Integrated Studies in Vascular Reactivity and Anaemia Correction Therapy in Endstage Kidney Disease Patients
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Failure, Chronic 0 0
Diabetes Mellitus, Type 1 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Surgery - Changing hemoglobin concentration

Treatment: Surgery: Changing hemoglobin concentration

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Change in pulse wave velocity at the three different haemoglobin levels
Timepoint [1] 0 0

Key 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)
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Uncontrolled BP: requiring dry weight or medication changes within 4 weeks prior to

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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Melbourne Health

Ethics approval
Ethics application status

Brief 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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Lawrence P McMahon, MD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications