PLC Systems has obtained approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to begin a clinical trial in Japan, assessing the ability of RenalGuard therapy to reduce the occurance of contrast-induced acute kidney injury (CI-AKI) in at-risk patients compared with the general expected rate.
The single-arm clinical trial is expected to enrol 60 patients with pre-existing kidney dysfunction and are undergoing a catheterisation procedure using contrast dye at two sites.
The primary endpoint is combined incidence of CI-AKI and serious in-hospital therapy-related adverse events compared with the expected rate based on patients' risk factors.
On completion of the study, the company expects to use its results for seeking marketing clearance in Japan.
The previously published studies of RenalGuard therapy and data from two cases where Japanese physicians used RenalGuard to protect patients at risk of CI-AKI have played a vital role in obtaining the MHLW approval.
Dr Ichiro Michishita, a Japanese cardiologist and expert in CI-AKI, successfully completed two cases using RenalGuard for the prevention of CI-AKI at Yokohama Sakae Kyosai Hospital, Yokohama, Japan, where Dr Michishita serves as director of the hospital's cardiovascular division.
Dr Michishita worked with the MHLW to outline a process for RenalGuard evaluation and approval in Japan.
Following the initial two cases, Dr Michishita met with the MHLW to present his findings and requested approval for the initiation of this 60-patient study.
PLC Medical Systems president and CEO Mark R Tauscher said: "The Japanese market has the potential to be the second largest market in the world for RenalGuard, based upon the number of cath lab procedures and patients undergoing these procedures with existing at-risk conditions for CI-AKI."
Designed to quickly removal of contrast dyes that are harmful to patients with impaired kidney function, RenalGuard technology can prevent the occurrence of CI-AKI in millions of at-risk patients.
This technology helps in maintaining a high urine output that allows the body to quickly eliminate the contrast agent and reduce its toxic effects.
CI-AKI can cause death or may require the patient to undergo a kidney transplant, and treatment of this condition can be very expensive.
In June, the company also secured a new patent entitled 'Patient Hydration Method' from the US Patent and Trademark Office for its RenalGuard therapy and the RenalGuard device.
RenalGuard is currently being studied in a pivotal trial in the US, as part of the FDA approval process, while it is CE-marked and being marketed in Europe and select countries around the world.