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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00226902




Registration number
NCT00226902
Ethics application status
Date submitted
26/09/2005
Date registered
27/09/2005
Date last updated
5/05/2015

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
Interactedd
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
Diabetes

Intervention/exposure
Study type
Interventional
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

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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT00226902
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00226902