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Can a simple drug make donated kidneys start working faster?

NCT ID NCT03646344

Disease control Sponsor: University of Edinburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the drug heme arginate can help transplanted kidneys work right away, instead of being slow to start. It included 47 adults receiving a kidney from a deceased donor. Participants got either the drug or a salt water solution at transplant and 24 hours later. The goal was to see if the drug reduces the need for dialysis and improves early kidney function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

47 people

The number who actually took part.

Started

Mar 2019

Finished

Feb 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute transplant rejection Delayed Graft Function end stage renal failure transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal transplant failure Renal transplant rejection

Contacts and locations

Locations

  • Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh

    Edinburgh, EH16 4UX, United Kingdom

  • NHS Lothian - Royal Infirmary of Edinburgh

    Edinburgh, Lothian, EH16 4SA, United Kingdom

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