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A Prospective UK Multicentre Study of Kidney Donors (EARNEST)

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ClinicalTrials.gov Identifier: NCT01769924
Recruitment Status : Active, not recruiting
First Posted : January 17, 2013
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
British Heart Foundation
University Hospital Birmingham NHS Foundation Trust
North Bristol NHS Trust
University Hospitals Coventry and Warwickshire NHS Trust
St. George's Hospital, London
Glasgow Western Infirmary
Sheffield Teaching Hospitals NHS Foundation Trust
Manchester University NHS Foundation Trust
Information provided by (Responsible Party):
Jonathan N. Townend, University Hospital Birmingham NHS Foundation Trust

Brief Summary:
Studies of patients with established kidney disease, even when this is mild, appear to show that they are at high risk of heart failure, stroke and sudden cardiac death. This may be because kidney disease causes stiffening of the arteries in the body which means that the heart and brain are damaged by high blood pressure. By studying patients before and after the removal of a kidney (uni-nephrectomy) for transplantation the investigators will find out for the first time in man the effect of an isolated reduction in kidney function on the structure and function of the cardiovascular system.

Condition or disease Intervention/treatment
Living Kidney Donors Other: Nephrectomy

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 463 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of A Reduction in Glomerular Filtration Rate After Nephrectomy on Arterial Stiffness (EARNEST)
Actual Study Start Date : February 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Group/Cohort Intervention/treatment
Live kidney donors
Nephrectomy
Other: Nephrectomy
Nephrectomy for the purposes of living kidney donation
Healthy controls
Who also meet criteria to donate a kidney



Primary Outcome Measures :
  1. Aortic Pulse Wave Velocity (aPWV) adjusted for mean arterial pressure and heart rate [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Clinic blood pressure [ Time Frame: 12 months ]
  2. Number of patients newly diagnosed with hypertension [ Time Frame: 12 months ]
    As defined by commencement of antihypertensive therapy

  3. Augmentation index (AIx) [ Time Frame: 12 months ]
  4. Central blood pressure [ Time Frame: 12 months ]
    Central haemodynamics

  5. N-terminal prohormone of brain natriuretic peptide (NT-proBNP) [ Time Frame: 12 months ]
  6. Urinary albumin: creatinine ratio (ACR) [ Time Frame: 12 months ]
  7. 24 hr Ambulatory Systolic Blood Pressure [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Urine, serum and plasma.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

Inclusion Criteria:

  • A donor group will be recruited from all patients undergoing donor nephrectomy.
  • A contemporaneous control group will be recruited from clinics, advertisements within and outside the institutions and from any local volunteer databases.

Exclusion Criteria:

  • These will be the same for donors and controls. The current nationally set exclusion criteria for donors include age/glomerular filtration rate (GFR) cutoff, diabetes mellitus, any history of cardiovascular or pulmonary disease, evidence of hypertensive end-organ damage, known left ventricular dysfunction (including ejection fraction < 40%) and atrial fibrillation.

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): NCT01769924


Locations
United Kingdom
University Hospital Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B17 0HT
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
British Heart Foundation
University Hospital Birmingham NHS Foundation Trust
North Bristol NHS Trust
University Hospitals Coventry and Warwickshire NHS Trust
St. George's Hospital, London
Glasgow Western Infirmary
Sheffield Teaching Hospitals NHS Foundation Trust
Manchester University NHS Foundation Trust
Investigators
Study Chair: John Cockcroft, PhD Cardiff
Study Director: Ian B Wilkinson Cambridge Heart Inc.
Principal Investigator: Jonathan N Townend Birmingham

Publications:
Responsible Party: Jonathan N. Townend, Consultant Cardiologist and Honorary Reader in Cardiology, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01769924     History of Changes
Other Study ID Numbers: A092761
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jonathan N. Townend, University Hospital Birmingham NHS Foundation Trust:
Kidney donors
Arterial stiffness
Blood pressure
Nephrectomy