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If you choose to participate, you will be participating in a randomised controlled ‘platform’ trial. Sometimes, we do not know how to manage a condition; to find out the best way to manage calciphylaxis we need to compare various treatments. You will be put into a group by chance (or ‘randomised’, like rolling a dice) to receive different treatment/s. The treatment you receive may be a placebo, which is a medication with no active ingredients or a procedure without any medical cost. If your calciphylaxis condition does not respond to the treatment assigned to you, your treatment may be “intensified”. This may include changing or adding new treatments.
This study aims to improve medical knowledge and may help patients in the future with calciphylaxis. The results of this study will provide doctors with important information about which treatments work best for wound healing in calciphylaxis.
We currently do not know how well, or even whether, the treatments will help you, which is why the research is needed.
All medical treatments involve some risk of harm. If you experience any side effects or new symptoms whilst on treatment, please discuss this with your study doctor. If you become unwell between hospital visits, please seek advice immediately, either from your treating hospital or from your GP. Please update the study team if you attend your GP or hospital for problems relating to calciphylaxis. Other known risks in this study are around blood collection. Wherever possible, your blood will be collected at the time of dialysis to minimise the need for additional needles. For most people, blood collection does not cause any serious problems. However, it is possible you may feel some discomfort and there may be some bruising, swelling or bleeding where the needle enters the skin.
Whilst you are taking the assigned treatment/s for this study, you will continue to receive your usual standard of care from your kidney doctor and the dialysis staff. However, there are some medications and supplements that will need to be stopped prior to participating in the study. This includes, but is not limited to: Warfarin Calcium and Vitamin D supplements Calcium-based phosphate binders
Your participation in this study is completely voluntary and there will be no cost to you. If you do not want to take part in this study you do not have to. You should feel under no obligation to participate in this study. Choosing not to take part in this study will not affect your current and future medical care in any way.
Your study data will be held electronically by the National Health and Medical Research Council Clinical Trials Centre and in paper and electronic format at site. The study data will be kept for at least 15 years from the end of the study, after which it will be securely destroyed. Any information obtained in connection with this study that can identify you will remain confidential and will not be disclosed without your permission, except as required by law. The information collected in the study database will be identified by a code number. Only your study doctor and the study team will be able to link the code number to you personally. This information will only be used for the purpose of this study and it will only be disclosed with your permission, except as required by law. The coded information entered in the study database will be stored in a ‘cloud’ server (a way of storing and accessing data electronically online rather than on a physical server), which is located outside Australia. The primary data storage location is Houston, Texas, USA.