{"id":6333,"date":"2024-02-28T13:15:27","date_gmt":"2024-02-28T13:15:27","guid":{"rendered":"https:\/\/edren.org\/ren\/?page_id=6333"},"modified":"2026-02-27T12:40:28","modified_gmt":"2026-02-27T12:40:28","slug":"imlifidase-enabled-transplantation","status":"publish","type":"page","link":"https:\/\/edren.org\/ren\/handbook\/transplant-handbook\/immunosuppression-protocol\/imlifidase-enabled-transplantation\/","title":{"rendered":"Imlifidase enabled transplantation"},"content":{"rendered":"

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Imlifidase is licensed by SMC for desensitisation treatment of highly sensitised adult kidney transplant patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.<\/span><\/p>\n

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  1. Candidate patients are decided at the MDT to be both immunologically (as per SMC criteria<\/a>) and clinically eligible to received the drug.<\/span><\/li>\n
  2. Patient require re-transplant vaccinations for pneumococcus, meningococcus (tetravalent and sero-group B), influenza and SARS-CoV-2.<\/span><\/li>\n
  3. Patients are given the Edinburgh patient information leaflet (attached below) and counselled in clinic\/Near Me.<\/span><\/li>\n
  4. If patients agree, then HLA specificities are de-listed as per local policy and discussion between H&I and transplant teams. At this point pharmacy will be contacted to order in the drug and de-listing should not occur until the drug is on site<\/u>, as it may take some days.<\/span><\/li>\n
  5. Patient will require enhanced HLA antibody screening while waiting for an offer \u2013 every 4 weeks.<\/span><\/li>\n
  6. If an offer is received for the patient, the H&I scientist will liaise with the duty\/on-call transplant team and indicate that this patient is on the imlifidase pathway.<\/span>\n
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    1. The patient should have a 10ml clotted sample sent to H&I on arrival for HLA antibody testing. In addition, a 20ml EDTA tube is required for later crossm<\/span>atch<\/u>. The antibody test may not need to be repeated if done within the past 4 weeks but we still require the sample for retrospective testing.<\/span><\/li>\n
    2. The results of the HLA antibody testing will determine if imlifidase is needed or not. It may be appropriate to transplant without imlifidase if the transplant is deemed lower risk e.g. historic antibodies only or low level current antibodies. This decision will need to be made by the duty\/on-call transplant team (nephrology & surgery) in discussion with the H&I scientist.<\/span>\n
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      1. If a non-imlifidase transplant is possible from assessment of the HLA antibody data, then the wet crossmatch using donor peripheral blood samples will be performed to further assess the immunological risk of this approach.<\/span><\/li>\n<\/ol>\n<\/li>\n
      2. When a patient receives an offer for an imlifidase enabled transplant, the on-call co-ordinator will notify pharmacy at the earliest opportunity that imlifidase is required. The usual cascade system for contacting pharmacy will be used:<\/span>\n
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        1. Monday-Friday 8:30-17:00 via Transplant Pharmacist (bleep 2294).<\/span><\/li>\n
        2. Weekend – within opening hours (Sat 9:00-15:00, Sun 10:00-14:30) via dispensary ext. 22911 or 22912.<\/span><\/li>\n
        3. Outwith pharmacy opening hours \u2013 on-call pharmacist contacted via switchboard.<\/span><\/li>\n<\/ol>\n<\/li>\n
        4. Once the organ is inspected by the transplant surgeon and deemed transplantable, imlifidase may be administered if deemed necessary.<\/span><\/li>\n
        5. A repeat 5ml clotted sample should be sent 4 hours post-imlifidase<\/u>. <\/strong>At 6hours post-imlifidase, repeat 2 x 5ml clotted samples – for HLA antibodies and wet cross-match using spleen\/lymph nodes – should be sent<\/u>.\u00a0<\/strong><\/span>\n
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          1. The decision to transplant will be based on the 6 hour DSA and crossmatch tests. The 4 hour sample is for local audit\/learning. It may be that retrospectively we see that a 4 hour sample will suffice. Until then, decision making will be based on the 6 hour sample.<\/span><\/li>\n<\/ol>\n<\/li>\n
          2. If the 6 hour HLA antibody sample is negative, which would be expected, the transplant can go ahead.<\/span>\n
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            1. If this sample remains significantly DSA positive, it is a contra-indication to transplantation. In Scotland, the drug is licensed for one repeat dose if necessary. It is predicted that this is very unlikely to occur so it should be discussed with H&I and a second clinical opinion in the unit before proceeding to a repeat dose. *<\/span><\/li>\n
            2. If the cross-match remains positive despite no HLA antibodies being present, this is likely due to a non-IgG antibody and the transplant could likely go ahead after a discussion with the duty\/on-call transplant team. <\/span><\/li>\n
            3. In practice the DSA test may come back some time before the flow cross-match. If the DSA test is negative, as would be expected, it may be reasonable to proceed without the full cross-match in an effort to keep the cold ischaemic time from being prolonged.<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n<\/li>\n
            4. After transplantation, HLA antibody samples should be sent at the following intervals; day +4, +7, +10, +14, weekly thereafter for 6 weeks or as clinically indicated in response to graft dysfunction. Following this if patient\u2019s function is stable, samples will be tested at 3 months, 6 months and annually thereafter. <\/span>More frequent assessments may be warranted if\/when DSA rebound occurs. For example, daily or near daily assessments in the days following DSA re-emergence may help guide dosing of IgG based therapies (see later note regarding alemtuzumab potentially not working on Day 4).<\/li>\n
            5. For patients outwith Lothian, communication between the home team and an Edinburgh transplant nephrologist should occur once weekly for at least the first 6 weeks. This arrangement should be clarified at discharge and could be the duty transplant nephrologist or one of the nephrologists who do the regular outreach MDTs.\u00a0<\/span><\/li>\n<\/ol>\n

              *Currently a second dose will not be possible even if indicated as stock is ordered on a case by case basis so we will be in a similar situation to the rest of the UK.<\/span><\/p>\n

              Note: a group and save must be sent to SNBTS on admission to the ward. This is already standard for all transplant patients. The additional importance for imlifidase patients is that SNBTS want to ensure that full red cell antigen testing is performed as imlifidase could interfere with this assessment if the patient subsequently needs a red cell transfusion.<\/span><\/p>\n

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              Treatment Protocol for Imlifidase in highly sensitised kidney transplant patients\u00a0<\/span><\/p>\n