Heme Arginate in Transplantation Study

NCT ID: NCT03646344

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2021-02-23

Brief Summary

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.

Conditions

Renal Transplant Rejection; Renal Transplant Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Group

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.

Group Type: ACTIVE_COMPARATOR

Heme Arginate 25 MG/ML

Intervention Type: DRUG

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 Group

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.

Group Type: PLACEBO_COMPARATOR

0.9% Sodium-chloride

Intervention Type: DRUG

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).

Interventions

Heme Arginate 25 MG/ML

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).

Intervention Type: DRUG

0.9% Sodium-chloride

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients undergoing a kidney only transplant, or a dual kidney transplant, from a deceased donor
• At least 18 years of age, no upper limit
• Receiving standard immunosuppression for the individual centre
• (where applicable) Meets co-enrolment criteria outlined in section 4.4 of the protocol

Exclusion Criteria

• Kidney transplant patients as part of a multi-organ transplant e.g. with pancreas or liver
• Known hypersensitivity to heme arginate
• Unable to give informed consent
• Patients with porphyria, irrespective of whether they have received heme arginate or not, will be excluded
• Previous randomisation into this study (or HOT study)
• Women who are pregnant or lactating
• Kidneys that have undergone Ex-vivo Normothermic Perfusion (EVNP)
• Patients with known liver disease, epilepsy, brain injury or disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kidney Cancer UK

OTHER

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorna Marson

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

NHS Lothian - Royal Infirmary of Edinburgh

Edinburgh, Lothian, United Kingdom

Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh

Edinburgh, , United Kingdom

Countries

United Kingdom

Other Identifiers

AC17065

Identifier Type: -

Identifier Source: org_study_id