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ACTIVE NOT RECRUITING

NCT07825025

PHASE2/PHASE3

A Multicenter, Randomized, Double-blind, Positive-control, Non-inferiority Clinical Trial on the Effectiveness and Safety of HCA-N Solution for the Preservation of Kidney Grafts During Kidney Transplantation

Sponsor: Zhongnan Hospital

View on ClinicalTrials.gov

Summary

To verify the effectiveness and safety of the HCA-N solution in actual clinical preservation, this study intends to conduct a prospective, randomized, and positive control clinical trial. Using the classic HTK solution as a reference, the study will focus on evaluating the performance of the HCA-N solution in terms of the incidence of delayed recovery of transplant kidney function and the speed of early renal function recovery, with the aim of providing better preservation solution selection and high-level evidence-based guidance for clinical practice in kidney transplantation.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-12-05

Completion Date

2028-04-09

Last Updated

2026-09-17

Healthy Volunteers

Conditions

Kidney Transplant

Interventions

DRUG

HCA-N Solution

Experimental Group using HCA-N Solution for the preservation of donor kidneys in renal transplantation

DRUG

HTK Solution

control group using HTK Solution in kidney organ transplantation

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.

Locations (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China