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New fluid aims to keep donated kidneys healthier

NCT ID NCT07825025

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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers compare two fluids used to preserve donor kidneys before transplant: a new solution called HCA-N and the standard HTK solution. The trial enrolls 250 first-time kidney transplant recipients aged 18 to 65. Doctors check how often kidneys need dialysis within the first week after surgery and how quickly they start working, to see if HCA-N is at least as good as the standard fluid.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HCA-N solution, a fluid used to preserve donor kidneys before transplant
What this could lead to
If HCA-N preserves kidneys better than the standard fluid, more transplanted kidneys could start working quickly and fewer patients might need dialysis right after surgery.
What could go wrong
The trial may show HCA-N works no better than the standard HTK fluid, or it may help only certain donor kidneys. Preservation fluids carry a small risk of tissue irritation or poor organ function if they do not protect the kidney well.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

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 to 65 years

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: * Recipients must meet all of the following criteria 1-4:(1)Age 18 to 65 years (inclusive), regardless of gender;(2)Diagnosed as eligible for allogeneic renal transplantation and willing to undergo allogeneic renal transplantation;(3)Understand and agree to comply with the study requirements and voluntarily sign the informed consent form;(4)Require renal transplantation and be first-time transplant recipients. Donors must meet all of the following criteria 5-6:(5)Donor kidney source aged 18 to 65 years (inclusive), regardless of gender;(6)Donor's last serum creatinine before kidney procurement \< 2 mg/dL (177 μmol/L), and not having received hemodialysis. Exclusion Criteria: * (Recipients meeting any of the following criteria 1-8 will be excluded):(1)Planned for dual kidney transplantation;(2)Planned for multi-organ combined transplantation;(3)History of previous organ transplantation;(4)Concurrent severe diseases, such as severe hepatic impairment, cardiopulmonary insufficiency, coagulation disorders, etc.;(5)Diagnosis of malignant tumor within 5 years prior to enrollment (except for adequately treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, prostate cancer not requiring antitumor therapy, thyroid cancer, breast ductal carcinoma in situ, and urothelial carcinoma below T1 stage);(6)Panel reactive antibody (PRA) \> 10%;(7)Pregnant or lactating women;(8)Participation in other drug or device clinical trials within 3 months prior to enrollment. Donors meeting any of the following criteria will be excluded:(1)Donor has received renal replacement therapy (hemodialysis/CRRT) prior to screening;(2)Donor has infectious diseases unsuitable for transplantation.(3)Other requirements:ABO blood type incompatibility between donor and recipient;Donor kidney warm ischemia time \> 10 min, or cold ischemia time \> 24 h;Mechanical perfusion preservation required as assessed by the investigator;Other conditions that the investigator deems inappropriate for participation in this trial.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071, China

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