New fluid aims to keep donated kidneys healthier
NCT ID NCT07825025
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A new tool aims to predict and prevent living kidney donor Drop-Out
- Can digital tools and training help more kidney patients get transplants?
- Can a new preservation fluid keep donor kidneys healthier for transplant?
- Oxygen bath for donor kidneys: a new hope for transplant success?
- Can smarter monitoring of transplant drugs prevent rejection in kids?