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

September 13, 2026 updated by: Zhongnan Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Title：A Multicenter, Randomized, Double-Blind, Positive-Controlled, Non-Inferiority Clinical Trial to Evaluate the Efficacy and Safety of HCA-N Solution for Preservation of Donor Kidneys in Renal Transplantation Study Design：Multicenter, randomized, double-blind, positive-controlled, non-inferiority trial Device Name：Test Group: HCA-N Solution；Control Group: HTK Solution； Regulatory Classification：Class III Study Objective：To evaluate the safety and efficacy of HCA-N Solution for the preservation of donor kidneys in renal transplantation, through a comparative study with HTK Solution in kidney organ transplantation.

Indication for Use：This product is intended for flushing and preserving isolated kidneys for clinical renal transplantation.

Sample Size：250 subjects in total, with 125 subjects in each of the test and control groups.

Study Centers：Approximately 20 centers Primary Endpoint：(1)Percentage of subjects experiencing delayed graft function (DGF) post-transplantation. (2)DGF is defined as the need for dialysis within 1 week after transplantation.

Secondary Endpoints：(1)Percentage of subjects with eGFR > 30 mL/(min·1.73 m²) within 28 days post-transplantation;(2)Time to first eGFR > 30 mL/(min·1.73 m²) within 28 days post-transplantation;(3)Change in eGFR from baseline (the last value before transplantation) at Days 1, 3, 7, 14, and 28 post-transplantation;(4)Device deficiencies.

Safety Evaluation Indicators：Adverse events (AEs) and serious adverse events (SAEs) and their incidence rates;Vital signs, physical examination, laboratory test parameters, etc.

Inclusion Criteria (Both donor and recipient must meet their respective inclusion criteria for enrollment) 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.

Study Procedures

Screening Period (V1, D-14 to D-1):

Screen potential kidney transplant donors and recipients for eligibility. Obtain signed informed consent. Collect recipient demographic information, medical history, treatment history, and current disease history. Collect blood type (ABO and Rh), immunological test results (PRA, donor/recipient crossmatch test, HLA typing). Complete screening assessments: vital signs, physical examination, complete blood count, urinalysis (if applicable, same below), blood biochemistry, coagulation function, transfusion-transmitted infection markers, pregnancy test (for women of childbearing potential only), 12-lead ECG, and chest CT or X-ray. (Except for vital signs and physical examination, results from tests performed within 7 days prior to screening are acceptable.) Record the subject's preoperative eGFR baseline value (last value before transplantation).

Surgery Day (V2, D0) Enrollment/randomization assignment; Record vital signs; Renal transplantation surgery; Kidney preservation; Observe device deficiencies; Record post-transplant dialysis events; Record adverse events and concomitant treatments. Follow-up Visit (V3, D1) Record vital signs; Laboratory tests: complete blood count, blood biochemistry, and urinalysis; Record eGFR on Day 1 post-transplantation; Record dialysis events post-transplantation; Record adverse events and concomitant treatments. Follow-up Visit (V4, D3) Record vital signs; Laboratory tests: complete blood count, blood biochemistry, and urinalysis; Record eGFR on Day 3 post-transplantation; Record dialysis events post-transplantation; Record adverse events and concomitant treatments. Follow-up Visit (V5, D7 ± 1) Record vital signs; Laboratory tests: complete blood count, blood biochemistry, and urinalysis; Record eGFR on Day 7 post-transplantation; Record dialysis events post-transplantation; Record adverse events and concomitant treatments. Follow-up Visit (V6, D14 ± 2) Record vital signs;

Laboratory tests: complete blood count, blood biochemistry, and urinalysis; Record eGFR on Day 14 post-transplantation; Record dialysis events post-transplantation; Record adverse events and concomitant treatments. Follow-up Visit (V7, D28 ± 3) Record vital signs and physical examination; Laboratory tests: complete blood count, blood biochemistry, and urinalysis; Coagulation function, pregnancy test (for women of childbearing potential only); 12-lead ECG; Chest CT or X-ray; Record eGFR on Day 28 post-transplantation; Record dialysis events post-transplantation; Record adverse events and concomitant treatments. Long-term Follow-up Record eGFR; Record graft survival status and patient survival information; Record device-related adverse events. Statistical Analysis Primary Endpoint: The primary endpoint is the percentage of subjects experiencing delayed graft function (DGF) post-transplantation. Chi-square test / corrected chi-square test / Fisher's exact test will be used for comparison between groups, and 95% confidence intervals will be calculated.

Secondary Endpoints:

Percentage of subjects with eGFR > 30 mL/(min·1.73 m²) within 28 days post-transplantation: Chi-square test / corrected chi-square test / Fisher's exact test will be used for comparison between test and control groups, and 95% confidence intervals will be calculated; Time to first eGFR > 30 mL/(min·1.73 m²) within 28 days post-transplantation: Kaplan-Meier method will be used to estimate median time, 25%/75% percentiles, and their 95% confidence intervals; Kaplan-Meier curves will be plotted; Changes in eGFR from baseline at Days 1, 3, 7, 14, and 28 post-transplantation: Descriptive analysis (sample size, mean, standard deviation) will be performed for each group; between-group comparisons will be made using t-test / rank-sum test.

Safety Analysis: To be performed based on the Safety Set (SS). The number of cases, number of subjects, and incidence rates of adverse events and serious adverse events will be calculated. Adverse events will be summarized by severity, SOC/PT, relationship to the study product, etc., in terms of number of events, number of subjects, and incidence rates. Detailed listings of adverse events will be provided. Physical examination, vital signs, 12-lead ECG, laboratory, and other test results will be summarized descriptively.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Zhongnan Hospital of Wuhan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evaluate the Efficacy and Safety of HCA-N Solution for Preservation of Donor Kidneys
To evaluate the safety and efficacy of HCA-N Solution for the preservation of donor kidneys in renal transplantation, through a comparative study with HTK Solution in kidney organ transplantation.
Drug: HCA-N Solution
Experimental Group using HCA-N Solution for the preservation of donor kidneys in renal transplantation
Sham Comparator: comparative with HTK Solution in kidney organ transplantation.
The commonly used methods in clinical practice
Drug: HTK Solution
control group using HTK Solution in kidney organ transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects experiencing delayed graft function (DGF) post-transplantation.
Time Frame: Baseline at Days 1, 3, 7, 14, and 28 post-transplantation
DGF is defined as the need for dialysis within 1 week after transplantation.
Baseline at Days 1, 3, 7, 14, and 28 post-transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2025

Primary Completion (Estimated)

April 9, 2028

Study Completion (Estimated)

April 9, 2028

Study Registration Dates

First Submitted

September 13, 2026

First Submitted That Met QC Criteria

September 13, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 13, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QD-QGBC-2512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The clinical project is underway and the data must be kept confidential.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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