Plain English Summary
Background and study aims
Calcific uraemic arteriolopathy or calciphylaxis is a disease caused by the build-up of calcium on the walls of the small blood vessels which supply the skin and/or muscle. This leads to reduced blood flow causing rashes, ulcers and pain in the affected tissues. It commonly affects the legs and arms but can affect the torso, back or breasts. It occurs almost exclusively in patients with chronic kidney disease but remains very rare, with about 1 case per year for every 600 dialysis patients in the UK. The trigger for the disease is not known but may include local injury. There is no specific treatment as yet that has been shown to work in many or most cases. Doctors often concentrate on getting the balance of minerals in the body right (e.g., calcium and phosphate control). This may require changing dialysis regimes, changing medications or considering treatment for overactive parathyroid glands. In addition, health-care teams focus on pain control, good nutrition and excellent ulcer care if the skin has broken down. This collaborative research project with the UK and Germany aims to find out if there is anything in their treatment or previous blood tests to help us identify who may be at risk of calciphylaxis.
Who can participate?
Anyone over the age of 18 with a diagnosis of chronic kidney disease and calciphylaxis can be entered into the study.
What does the study involve?
We will collect clinical information from the patients including details of their treatment and any other diseases they have, and we will collect blood and tissue samples (skin biopsy) to diagnose the condition.
What are the possible benefits and risks of participating?
The tests we will carry out will help increase our understanding of what the disease process is, so that we can improve our treatments in the future..
Where is the study run from?
Salford Royal NHS Foundation Trust (UK).
When is the study starting and how long is it expected to run for?
The study started in March 2012 and will run until September 2021.
Who is funding the study?
This independent study was designed by clinicians and has been funded by Amgen (UK).
Who is the main contact?
Dr Smeeta Sinha
smeeta.sinha@srft.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Smeeta Sinha
ORCID ID
Contact details
Department of Renal Medicine
Salford Royal NHS Foundation Trust
Stott Lane
Greater Manchester
Salford
M6 8HD
United Kingdom
smeeta.sinha@srft.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11704
Study information
Scientific title
The UK Calciphylaxis Study: a cohort study
Acronym
Study hypothesis
Calciphylaxis is a rare condition which results in small arteries becoming calcified. This results in painful ulceration of the skin which in turn can result in infection and further damage to tissue. It is associated with a high mortality rate (6080%).
Consequently research into this area is important. The aims of this study are to determine the following:
1. What is the natural history of the disease?
2. What risk factors are associated with development and progression of calciphylaxis?
3. Which treatments currently in clinical practice confer a favourable outcome?
4. What are the underlying disease processes?
These aims will be achieved by collecting information on medications, clinical parameters, local laboratory tests, measuring specific proteins and molecules in blood and tissue as well as studying patients DNA profiles.
More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=11704
Ethics approval
First MREC 12/09/2011, ref: 11/NW/0528
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic kidney disease/ calciphylaxis
Intervention
Baseline clinical information on comorbidity, renal replacement therapy (RRT), medications, standard laboratory variables, skin lesions and diagnosis.
Plasma/Serum and clotting samples will be taken at baseline, week 1 and 2, 1 month and after full healing should this occur. Samples will be tested for serum levels of promoters and inhibitors of calcification, and clotting factor deficiencies. A DNA sample will be taken at baseline. Four monthly follow-up clinical and laboratory data collection until full recovery or death. Final bloods will be taken after full healing should this occur.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Plasma/Serum and clotting samples measured at baseline, week 1 and 2, 1 month
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/03/2012
Overall trial end date
01/09/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female, age more than equal to 18 years
2. Any patient with chronic kidney disease
3. Clinical diagnosis of calciphylaxis
4. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 200
Participant exclusion criteria
Patients who cannot give informed consent
Recruitment start date
01/03/2012
Recruitment end date
01/09/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Renal Medicine
Salford
M6 8HD
United Kingdom
Sponsor information
Organisation
Salford Royal NHS Foundation Trust (UK)
Sponsor details
Clinical Sciences Building
Stott Lane
Salford
M6 8HD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Amgen (UK)
Alternative name(s)
Amgen Inc., Applied Molecular Genetics Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
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