Condition category
Urological and Genital Diseases
Date applied
22/03/2012
Date assigned
24/09/2012
Last edited
14/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 (60–80%).

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 patient’s 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 measures

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

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

http://www.srft.nhs.uk/

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

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes