The Effectiveness and Safety of Hypertonic Citrate Adenine-New (HCA-N) Solution for the Preservation of Kidney Grafts During Kidney Transplantation

This is a multicenter, randomized, double-blind, positive-controlled, non-inferiority clinical trial evaluating HCA-N Solution versus Histidine-Tryptophan-Ketoglutarate (HTK) Solution for the preservation of donor kidneys in renal transplantation. HCA-N Solution is a Class III device intended for flushing and preserving isolated kidneys for clinical renal transplantation. Approximately 250 subjects will be enrolled, with 125 subjects in the test group and 125 in the control group, across approximately 20 centers. Donor-recipient pairs must meet the protocol-defined eligibility criteria; eligibility details are provided in the Eligibility Criteria section, and randomization will be 1:1 to the test or control group.

During the screening period (Visit 1 [V1], Day -14 to Day -1 [D-14 to D-1]), potential donors and recipients will be screened for eligibility, informed consent will be obtained, and baseline demographic, medical, immunological, and laboratory information will be collected. The recipient's preoperative baseline estimated glomerular filtration rate (eGFR) value, defined as the last value before transplantation, will be recorded.

On surgery day (Visit 2 [V2], Day 0 [D0]), enrollment and randomization will occur. Vital signs will be recorded, renal transplantation surgery will be performed, and the donor kidney will be flushed and preserved using the assigned preservation solution. Device deficiencies, post-transplant dialysis events, adverse events (AEs), and concomitant treatments will be recorded.

Follow-up visits will occur at Visit 3 (V3, Day 1 [D1]), Visit 4 (V4, Day 3 [D3]), Visit 5 (V5, Day 7 [D7] ± 1), Visit 6 (V6, Day 14 [D14] ± 2), and Visit 7 (V7, Day 28 [D28] ± 3). At these visits, vital signs, laboratory tests including complete blood count, blood biochemistry, and urinalysis, eGFR, dialysis events, adverse events, and concomitant treatments will be recorded. The Day 28 visit will also include physical examination, coagulation function, pregnancy testing for women of childbearing potential, 12-lead electrocardiogram (ECG), and chest computed tomography (CT) or X-ray. Long-term follow-up will collect eGFR, graft survival status, patient survival information, and device-related adverse events.

Efficacy will be assessed primarily by the occurrence of delayed graft function (DGF) after transplantation, with additional renal function parameters within 28 days post-transplantation as specified in the Outcome Measures section. Safety will be evaluated through AEs, serious adverse events (SAEs), vital signs, physical examination, laboratory parameters, ECG, and other protocol-specified assessments.

Statistical analysis will be performed according to prespecified analysis sets. For the primary endpoint, between-group comparisons will use chi-square test, corrected chi-square test, or Fisher's exact test as appropriate, with 95% confidence intervals calculated. Binary secondary endpoints will be analyzed using similar categorical methods. Time-to-event endpoints will be analyzed using the Kaplan-Meier method, including median time, 25%/75% percentiles, 95% confidence intervals, and Kaplan-Meier curves. Continuous eGFR changes from baseline at Days 1, 3, 7, 14, and 28 post-transplantation will be summarized descriptively by group and compared using t-test or rank-sum test as appropriate. Safety analyses will be based on the Safety Set (SS) and will summarize AEs and SAEs by number of events, number of subjects, and incidence rates; AEs will be summarized by severity, System Organ Class (SOC)/Preferred Term (PT), and relationship to the study product. Physical examination, vital signs, 12-lead ECG, and laboratory results will be summarized descriptively.