Vascular Reactivity in Kidney Disease Patients

• ClinicalTrials.gov Identifier: NCT00226902
• Recruitment Status: Completed
• First Posted: September 27, 2005
• Last Update Posted: May 5, 2015
• Sponsor: Melbourne Health
• Information provided by: Melbourne Health

Tracking Information

• First Submitted Date: September 26, 2005
• First Posted Date: September 27, 2005
• Last Update Posted Date: May 5, 2015
• Study Start Date: September 2006
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 8, 2007): Change in pulse wave velocity at the three different haemoglobin levels
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vascular Reactivity in Kidney Disease Patients
• Official Title: Integrated Studies in Vascular Reactivity and Anaemia Correction Therapy in Endstage Kidney Disease Patients

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.

• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

• Intervention: Procedure: Changing hemoglobin concentration
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 26, 2005): 15
• Original Enrollment: Same as current
• Actual Study Completion Date: September 2013
• Actual Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT00226902
• Other Study ID Numbers: Interactedd
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Melbourne Health
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lawrence P McMahon, MD; Melbourne Health

• PRS Account: Melbourne Health
• Verification Date: May 2015