A Phase 3 interventional study of Heme Arginate 25 MG/ML and 0.9% Sodium-chloride in Renal Transplant Rejection and Renal Transplant Failure, sponsored by University of Edinburgh. Terminated at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by University of Edinburgh · Phase 3, Interventional, and Treatment
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. The investigators 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. The investigators 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 listed for a kidney transplant. Further discussions will be had with them when admitted for transplant, and they will be offered the opportunity to participate. Consent will not be taken until the patient is admitted for transplantation. Following consent, participants 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, treatment will be the same as any other patient undergoing a kidney transplant. Information about recovery from surgery, and specifically about kidney function, will be collected, but will not require additional blood tests. The study period ends after the first 7 days post-transplant, although longer term data will be collected from routine follow up appointments. Participants will be asked to complete a simple quality of life questionnaire 3 times: just before transplant, at approximately one week and three months after transplant.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's enrollment of 47 is below the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will receive Heme Arginate (IMP) at a dose of 3mg/kg over 30mins. Participants will receive infusions of the IMP at 2 time-points, the first prior to surgery (transplantation), and the second 20-28 hours later. At each infusion, the IMP will be followed by a 100ml infusion of 0.9% Sodium Chloride over 15mins.
Drug: Heme Arginate 25 MG/ML
Will receive a 100ml infusion of 0.9% Sodium Chloride (placebo) over 30mins. Participants will receive infusions at 2 time-points, the first prior to surgery, and the second 20-28 hours later. At each infusion, the placebo will be followed by a further 100ml infusion of 0.9% Sodium Chloride over 15mins.
Drug: 0.9% Sodium-chloride
Drug page: Heme arginate
IMP - to be administered at a dose of 3mg/kg to a maximum dose of 250mg over 30 mins. Participants will receive intervention twice during the trial, one on Day 0 (day of transplantation) and then again on D1 (20-28 hours after dose 1).
Placebo - 100ml of 0.9% Sodium Chloride will be given over 30 mins. Participants will receive intervention twice during the trial, one on Day 0 (day of transplantation) and then again on D1 (20-28 hours after dose 1).
Delayed Graft Function
The incidence of delayed graft function, defined as failure of a spontaneous fall in creatinine of \>10% for each 3 consecutive day period in the first week following transplantation, with comparison between the two randomised groups.
Time frame: 1 week post transplant
Requirement for dialysis
The number of participants requiring dialysis within the first week post-transplant
Time frame: 1 week post transplant
Time to functioning graft
The number of days to functioning graft, defined as the spontaneous fall in creatinine of greater than, or equal to 10% over a period of 3 consecutive days in the first 7 days post transplant
Time frame: 1 week
Length of hospital stay
The number of days spent in hospital, along with level of care (ward/HDU/ITU), for the index admission (transplantation admission)
Time frame: 3 months
Creatinine levels
Serum creatinine levels at 1 and 3 months post-transplant across both randomised groups
Time frame: 3 months
Acute rejection
The number of participants with biopsy-proven acute rejection within the first 3 months post-transplant
Time frame: 3 months
SF36 Quality of Life
A comparison of differences between groups in patient reported quality of life using the SF36
Time frame: Up to 3 months post transplant
Cost per QALY gained
Using data derived from the SF36 to weight survival for quality of life, Quality Adjusted Life Year (QALY) will be assessed
Time frame: Up to 3 months post transplant
1 Year graft survival
Graft survival rates at 1 year post transplant will be obtained from routinely collected data and differences between treatment groups assessed.
Time frame: 1 year
1 year recipient survival
Recipient survival rates at 1 year post transplant will be obtained from routinely collected data and differences between treatment groups assessed.
Time frame: 1 year
Plan to share: Yes — Following publication of the primary paper, a de-identified individual participant data set will be submitted to a data archive for sharing purposes. Access to this data set will be under a controlled access model in line with ECTU policies at that time.
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Ran from Mar 2019 to primary completion in Mar 2020, 12 months.
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This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Heme arginate