The UK Calciphylaxis Study
| ISRCTN | ISRCTN34171966 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34171966 |
| Secondary identifying numbers | 11704 |
- Submission date
- 22/03/2012
- Registration date
- 24/09/2012
- Last edited
- 14/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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 2026.
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
Contact information
Scientific
Department of Renal Medicine
Salford Royal NHS Foundation Trust
Stott Lane
Greater Manchester
Salford
M6 8HD
United Kingdom
| smeeta.sinha@srft.nhs.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The UK Calciphylaxis Study: a cohort study |
| Study objectives | 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(s) | First MREC 12/09/2011, ref: 11/NW/0528 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2012 |
| Completion date | 30/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 200 |
| Key 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 |
| Key exclusion criteria | Patients who cannot give informed consent |
| Date of first enrolment | 01/03/2012 |
| Date of final enrolment | 01/09/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M6 8HD
United Kingdom
Sponsor information
Hospital/treatment centre
Clinical Sciences Building
Stott Lane
Salford
M6 8HD
England
United Kingdom
| Website | http://www.srft.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/019j78370 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Amgen Inc., Applied Molecular Genetics Inc.
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | 01/10/2021 | 14/10/2022 | Yes | No |
Editorial Notes
14/10/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The overall end date was changed from 01/09/2021 to 30/09/2026.
3. The plain English summary was updated to reflect these changes.
22/07/2020: The publication and dissemination plan was added.
