PATIENT DETAILS

Patient name		Date of birth
CHI number		Sex
Special requirements

STATEMENT FOR PRACTITIONER
(to be filled in by practitioner with appropriate knowledge of proposed procedure)

You are being asked to give your consent to the staff in the Glasgow Renal and Transplant Unit for treatment with imlifidase to facilitate a kidney transplant.

We are considering the use of imlifidase to increase the chances of you getting a transplant. We are doing this because you have a high level of antibodies to other human tissue types, and this means less than {{current_compatible_num}} in 10,000 donors () of kidney donors are compatible with you.

Imlifidase is a new drug, which removes antibody and might allow you to have a transplant which could not be done without it. But it brings additional risks and side effects, including the need for additional treatment after the transplant.

What is imlifidase?

Imlifidase is an enzyme which breaks up antibodies. This includes harmful antibodies to other human tissue types but also helpful antibodies that are part of your immunity to infection. It is a treatment that can only be given once.

Imlifidase allows us to accept kidneys from donors where you have some antibody against their tissue type, but it does not work well if you have very high levels of antibody. The option of imlifidase does mean that we can consider donors where you have low levels of antibody, so you might go from less than {{current_compatible_num}} in 10,000 donors () being compatible to up to {{new_compatible_num}} in 10,000 () being compatible, which increases the chances of getting a match but the waiting time may still be long. We may extend criteria in stages so that up to {{new_compatible2_num}} in 10,000 () would be compatible

How is imlifidase used?

When you are matched to a donor, we will consider whether you have antibodies against that donor. If they are present, we will do a test called a cross-match to see if the antibody level is high enough to be harmful. If the cross-match is negative, we will be able to carry on with the transplant in the usual way.

If the cross-match is positive, then you have harmful antibodies and we would give the imlifidase treatment, wait 6 hours for it to have worked and then repeat the cross-match to check the antibodies have gone. If the second cross-match is negative, we can do the transplant. There is a 5% chance that the second cross-match is positive, meaning antibodies still present and active, and we would not be able to do the transplant.

Because imlifidase can only be given once, we will need to assess the kidney and be confident it is likely to work before we give it. If the kidney is damaged or we think the chances of it working well are below average, then we will decide not to go ahead. This means an increased chance of being called in for a kidney offer which does not then lead to a transplant.

If the transplant cannot go ahead for any reason after you receive the imlifidase, we may still be able to transplant you if we get an offer within the next couple of days, but after that any chance of a transplant depends on there being a fully compatible donor as you cannot get imlifidase again.

What additional treatment will I need?

Before we can give you imlifidase, you will need to be vaccinated against certain bacterial and viral infections, including flu and COVID-19. You may already be fully vaccinated, but if not you will need these.

After the transplant, there is a risk of the removed antibodies coming back. To reduce this risk we will give additional anti-rejection medication. There is a 40% risk of antibodies coming back, and if so you will need further treatment to reduce the levels, usually plasma exchange.

Plasma exchange passes your blood through a machine which removes the antibodies and plasma proteins and returns it to the body. It is a bit like dialysis. You may need several sessions of plasma exchange. Sometimes additional treatment is needed as well, which can include other drugs; surgical removal of your spleen may be needed as well, but that is rare.

What are the risks of imlifidase?

The standard risks of transplantation and immunosuppression all still apply, but there are additional risks to consider:

• there is an increased risk of infection compared with standard anti-rejection treatment, and you will need additional antibiotics and anti-viral drugs to reduce this risk.
• there is an increased risk of rejection of the kidney, and an increased risk of the transplant failing due to rejection
• the kidney will be on cold storage for longer while you are treated with imflidase and re-tested, so it is likely to need some days before it starts to work after the transplant
• your hospital stay would be longer, you will need more clinic visits after the transplant, and you are more likely to be readmitted after the transplant
• the transplant is more likely to fail early than a standard transplant. There is a 10% risk of transplant failure within 6 months compared to 5% risk with standard deceased donor transplants

Do I definitely need it?

No, you can choose not to have it, and you will not need to have it if you are matched to a compatible kidney. If you choose not to have it, you still remain on the waiting list for transplant and are still prioritised for any kidneys which are compatible, but you may have a long wait until a compatible kidney comes along. If you choose to be considered for imlifidase, then if you are offered a kidney we will see if you have antibodies to that donor and would only be given imlifidase if you need it.

What else should I know?

Treatment with imlifidase is complex and time consuming. It is not an easy process for the patient or the hospital. We do not think we could manage two or more patients on the ward getting the treatment at the same time. This means that if we had a kidney offer but had another patient on the ward already getting this treatment, we would either need to turn down the kidney offer or admit you to the hospital but only go ahead if imlifidase is not needed. We will try not to call you in if we think we are unlikely to be able to transplant, but don’t want you to miss any offers if there is a realistic chance of a negative crossmatch.

Practitioner's statement

I have explained the procedure named on this form to the patient in terms which, in my judgement, are suited to their understanding. In particular, I have fully explained: the intended benefits; appropriate alternatives which are available (including no treatment); any significant risks which may result from the procedure; and any extra procedures which may become necessary during the procedure (please specify major procedures above).

Signature of practitioner
Name and status	/
Date:	12/05/2026

STATEMENT TO BE COMPLETED BY PATIENT

You should read this form and the notes below carefully. If there is anything you do not understand ask the Practitioner for an explanation. If the information is correct and you understand the procedure, you should sign the form. You have the right to change your mind at any time, including after you have signed this form.

I understand:

• The procedure, important risks and appropriate alternatives which have been explained to me by the practitioner named on this form.
• That a practitioner other than the practitioner who has been providing treatment so far might carry out the procedure.
• That any procedure in addition to that named on this form will only be carried out if it is necessary and is reasonable in the circumstances, in relation to the medical treatment proposed, to safeguard or promote physical or mental health.
• That examination for the purpose of teaching will not be undertaken without my consent.

I agree:

• to the procedure named on this form
• to further treatment thay may be needed including medication and plasma exchanges
• to the emergency administration of blood or blood products

PATIENT CONSENT TO TREATMENT

Signature:	Date: 12/05/2026
Name:	CHI: