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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
White
hot2@ed.ac.uk
Ms
Lorna
Marson
lorna.marson@ed.ac.uk
Mrs
Jean
Antonelli
hot2@ed.ac.uk
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
Organ shortage for transplant has necessitated use of kidneys from older donors, increasing the chance that the
kidney will not work immediately or for as long as expected. We gave the drug heme arginate (HA) to 20 kidney
transplant patients in the first 24 hours after transplant, and showed that it may reduce kidney injury and is safe. We
plan to conduct a large study recruiting 600 patients to determine whether HA treatment increases the
number of kidney transplants that work immediately. If successful, HA may be introduced into clinical practice at the
end of this study.
Patients will be invited to take part in the study once they have been listed for a kidney transplant. Further discussions
will be had with them when admitted for a transplant, and they will be offered the opportunity to participate. Consent
will not be taken until they are admitted for transplantation. If they agree, they will be randomised to receive either 2
doses of the study drug, HA, or a salt water solution, one at the time of transplant, and one approximately 24 hours
later. Otherwise, their treatment will be the same as any other patient undergoing a kidney transplant. Information
about their recovery from surgery, and specifically about their kidney function, will be collected, but they will not require
additional blood tests. The study period ends after the first 7 days after transplant, although longer term data will be
collected from routine follow up appointments. Patients will be asked to complete a simple questionnaire about their
quality of life 3 times: just before transplant, at approximately one week and three months after transplant.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
Obtaining data from patient's medical notes Following consent to the trial, data will be collected by an appropriate member of the local clinical/research team, who will have been delegated the task. Data collected will be minimised to that required to answer the question and ensure patient safety. Data collection and storage will be in accordance with the principles of GCP. Data entered onto the study specific database will be in a linked anonymised form. Information linking the participant number with identifiable information will be held separately and securely, only accessible by designated research staff. Data collected for the study and entered onto the database will be identified by participant number only. As with all studies there is governance and regulations surrounding the maintenance of data storage. Storage and management of data will be in accordance with local policy and applicable law. Multi-centre study In order to recruit the required number of participants in a timely manner we need to involve as many of the transplant centres in the UK as possible. The trial will be managed by the Edinburgh Clinical Trials Unit (ECTU) who are experienced in running multi centre trials. Use of Heme Arginate Heme Arginate (HA) has been used safely, for over 30 years, in patients with porphyria and has been shown to have a low side effect profile. A previous trial (Phase IIb) by this group, was carried out in a single centre to evaluate the safety and efficacy of HA in patients receiving a deceased donor kidney transplant. The trial showed good efficacy with no significant adverse effects being reported.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by LOTHIAN and funded by Kidney Research UK (KRUK) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 41712
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
