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Vascular Reactivity in Kidney Disease Patients

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

Study Description
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.


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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrated Studies in Vascular Reactivity and Anaemia Correction Therapy in Endstage Kidney Disease Patients
Study Start Date : September 2006
Primary Completion Date : August 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00226902     History of Changes
Other Study ID Numbers: Interactedd
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Melbourne Health:
Diabetes
Hemoglobin
Dialysis
Vascular reactivity

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