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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00226902