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

NCT07825025 | Active Not Recruiting Phase 2

• 1 other identifier: QD-QGBC-2512
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant

Keywords

Kidney transplantation, donor kidney preservation solution, multi-center clinical trial

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects experiencing delayed graft function (DGF) 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

Study Arms (2)

Evaluate the Efficacy and Safety of HCA-N Solution for Preservation of Donor Kidneys

EXPERIMENTAL

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

comparative with HTK Solution in kidney organ transplantation.

SHAM COMPARATOR

The commonly used methods in clinical practice

Drug: HTK Solution

Interventions

HCA-N Solution DRUG

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

Evaluate the Efficacy and Safety of HCA-N Solution for Preservation of Donor Kidneys

HTK Solution DRUG

control group using HTK Solution in kidney organ transplantation

comparative with HTK Solution in kidney organ transplantation.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipients must meet all of the following criteria:
• Age 18 to 65 years (inclusive), regardless of gender.
• Diagnosed as eligible for allogeneic renal transplantation and willing to undergo allogeneic renal transplantation.
• Understand and agree to comply with the study requirements and voluntarily sign the informed consent form.
• Require renal transplantation and be first-time transplant recipients.
• Donors must meet all of the following criteria:
• Donor kidney source aged 18 to 65 years (inclusive), regardless of gender.
• Donor's last serum creatinine before kidney procurement \< 2 mg/dL (177 μmol/L), and not having received hemodialysis.

You may not qualify if:

• Recipients meeting any of the following criteria will be excluded:
• Planned for dual kidney transplantation.
• Planned for multi-organ combined transplantation.
• History of previous organ transplantation.
• Concurrent severe diseases, such as severe hepatic impairment, cardiopulmonary insufficiency, coagulation disorders, etc.
• 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).
• Panel reactive antibody (PRA) \> 10%.
• Pregnant or lactating women.
• Participation in other drug or device clinical trials within 3 months prior to enrollment.
• Donors meeting any of the following criteria will be excluded:
• Donor has received renal replacement therapy (hemodialysis or continuous renal replacement therapy \[CRRT\]) prior to screening.
• Donor has infectious diseases unsuitable for transplantation.
• Other requirements:
• ABO blood group system incompatibility between donor and recipient.
• Donor kidney warm ischemia time \> 10 minutes, or cold ischemia time \> 24 hours.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Interventions

Bretschneider cardioplegic solution

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start: December 5, 2025
• Primary Completion (Estimated): April 9, 2028
• Study Completion (Estimated): April 9, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)