Vascular Reactivity in Kidney Disease Patients

This study has suspended participant recruitment.
(Study under review due to the upper limit of Hb.)
Sponsor:
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00226902
First received: September 26, 2005
Last updated: May 28, 2013
Last verified: September 2006
  Purpose

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.


Condition Intervention
Kidney Failure, Chronic
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Procedure: Changing hemoglobin concentration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Studies in Vascular Reactivity and Anaemia Correction Therapy in Endstage Kidney Disease Patients

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • Change in pulse wave velocity at the three different haemoglobin levels

Estimated Enrollment: 15
Study Start Date: September 2006
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226902

Locations
Australia, Victoria
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: Lawrence P McMahon, MD Melbourne Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00226902     History of Changes
Other Study ID Numbers: Interactedd
Study First Received: September 26, 2005
Last Updated: May 28, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Melbourne Health:
Diabetes
Hemoglobin
Dialysis
Vascular reactivity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 22, 2014