Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
The dose or adequacy of dialysis treatments (removal of waste from the body) for kidney failure patients is currently assessed by the removal of urea, a waste product of protein turnover. However, simply changing dialysis treatments to increase the amount of urea removed has not been shown to increase patient survival. Cardiac disease is the most common cause of death in kidney failure patients, and additional risk factors for cardiac death have been reported for these patients. Newer treatment methods that can reduce these risk factors are necessary. The main aim of this study is to measure three key risk factors associated with increased risk of death in different groups of kidney failure patients. Another aim is to find out whether any of the current treatments for kidney failure reduce these risk factors. Information from this initial study would then hopefully be used for future research.

Who can participate?
Patients with long-term kidney disease who are treated by outpatient dialysis

What does the study involve ?
Skin auto fluorescence is measured using a non-invasive technique that shines a light onto the forearm skin and measures the reflection. This can be done when patients are sitting or lying down whilst having dialysis. In addition to the usual tests that are done during their routine medical care 10 ml of blood is taken when the patients are having their routine blood testing. If patients have not had a recent electrical recording of the heart (ECG) as part of their normal routine care (performed annually) an ECG is recorded to look at the variability in heart beats. The relationship between these risk factors and heart disease is assessed. Blood pressure is also measured using a standard blood pressure cuff placed on the arm, and the recording is used to find out the stiffness of the arteries and also measure the thickness of the artery at the wrist or foot using ultrasound. This is a non-invasive technique and can be performed as the patient has their dialysis treatment.

What are the possible benefits and risks of participating?
There may be no immediate benefits to any patient. However, if any of the tests performed show significant risk factors for heart disease, these will be made available to their supervising kidney consultant who may then make changes to their treatment. Apart from an additional blood test, all other tests are non-invasive and painless and can be performed whilst patients are having dialysis.

Where is the study run from?
Royal Free Hospital (UK)

When is study starting and how long is it expected to run for?
October 2013 to October 2015

Who is funding the study?
Royal Free Hospital (UK)

Who is the main contact?
Dr Andrew Davenport

Trial website

Contact information



Primary contact

Dr Andrew Davenport


Contact details

UCL Centre for Nephrology
Royal Free Hospital
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

Protocol version 1.1

Study information

Scientific title

Pilot study to review alternative assessments of adequacy of dialysis in patients with kidney failure: a prospective cohort study


Study hypothesis

Currently the amount of dialysis treatment given to patients with chronic kidney disease is based on the amount of urea removed during a dialysis session. Using this guideline for dosing dialysis, in the UK the 5-year survival of kidney dialysis patients is marginally better than that for ovarian cancer, and worse than that of bowel cancer. The trialists hypothesise that newer targets for treating kidney dialysis patients are required to improve survival.

Ethics approval

NRES Committee London - Camden & Islington, September 2013, REC ref: 13/LO/0912, IRAS project ID: 129559

Study design

Prospective cohort study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Renal and cardiac


Conventional markers of dialysis adequacy and in addition measurement of skin autofluorescence, plasma endotoxin and modified albumin.
Cardiovascular assessments: blood pressure (pulse wave velocity), ECG (with analysis for autonomic dysfunction), and measurement of diameter of radial or dorsalis pedis artery.

Intervention type



Not Applicable

Drug names

Primary outcome measure

To determine the practicability of measuring skin autofluorescence, endotoxin and modified albumin in the study population and whether these factors correlate with conventional markers of dialysis adequacy.

Blood samples will be taken at entry into the study and then at 12 months to determine concentrations of endotoxin and modified albumin. Similarly blood pressure, ECG and skin autofluorescence will be measured at study entry and then at 12 months. Measurements of arterial size will be made once at study entry.

Secondary outcome measures

To determine whether skin autofluorescence, endotoxin and modified albumin correlate with cardiovascular risk factors

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Treated for chronic kidney failure
2. Ability to provide informed consent

Participant type


Age group




Target number of participants

More than 100

Participant exclusion criteria

1. Unable to provide informed consent
2. Aged below 18 years

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Royal Free Hospital
United Kingdom

Sponsor information


Royal Free Hospital (UK)

Sponsor details

Pond street
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Royal Free Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/11/2017: No publications found, verifying study status with principal investigator.