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A new HC-A II solution for kidney preservation: A multi-center randomized controlled trial in China
Mingxing Sui1, Lei Zhang1, Jinghui Yang1
1Organ Transplantation Institute of PLA, Changzheng Hospital, Second Military Medical University, Shanghai, China (mainland).
Insights
The new Hypertonic Citrate Adenine II (HC-A II) solution shows similar efficacy and safety to the histidine-tryptophan-ketoglutarate (HTK) solution for kidney preservation. This finding supports HC-A II as a viable option for isolated kidney preservation.
Area of Science:
- Nephrology
- Transplantation
- Organ Preservation
Background:
- Hypertonic citrate adenine (HC-A) solution is widely used for kidney preservation in China.
- Over 30 years of clinical use confirm HC-A's safety and effectiveness.
- HC-A II was developed to meet higher standards in kidney preservation.
Purpose of the Study:
- To evaluate the efficacy and safety of HC-A II in isolated kidney preservation.
- To compare HC-A II against the histidine-tryptophan-ketoglutarate (HTK) solution.
Main Methods:
- A multi-center randomized controlled trial was conducted from 2008 to 2012.
- 137 patients received HC-A, and 140 patients received HTK.
- Donor/recipient demographics and cold ischemia times were comparable between groups.
Main Results:
- No significant differences were observed in delayed graft function (DGF) rates between HC-A II and HTK groups.
- Patient and graft survival rates were similar for both preservation solutions.
- Serum creatinine normalization within 28 days and safety evaluations showed no significant differences.
Conclusions:
- HC-A II demonstrates comparable efficacy to HTK for isolated kidney preservation.
- Both HC-A II and HTK are safe and effective preservation solutions for kidneys.
Background:
Hypertonic citrate adenine (HC-A) solution, containing citrate and adenine, has become the most widely used preservation solution in isolated kidney preservation in China. More than 30 years of clinical application has demonstrated that HC-A is safe and effective. With higher requirement for kidney preservation and less tolerance of preservation-related graft dysfunction, a new solution, HC-A II, for kidney preservation was developed by Shanghai Changzheng Hospital.
Material/Methods:
Upon approval from the State Food and Drug Administration of China (SFDA), a multi-center randomized controlled trial was performed to study the efficacy and safety of HC-A II in kidney preservation from 2008 to 2012, using histidine-tryptophan-ketoglutarate solution (HTK) as control (HC-A, n=137, and HTK, n=140). There were no differences with regard to donor and recipient demographics or cold ischemia.
Results:
The trial results showed no significant difference in DGF rate, or patient or graft survival between the 2 groups. No significant difference between the 2 groups was found in the percentage of patients whose serum creatinine (SCr) test results returned to normal within 28 days (P>0.05), nor were there a significant difference in safety evaluation (P>0.05).
Conclusions:
HC-A II and HTK appear to have similar efficacy in isolated kidney preservation.
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