PLC Systems, a medical device company, has obtained an approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to initiate a single-arm clinical trial in Japan using its RenalGuard therapy.
This approval is based on MHLW's review of previously published studies of RenalGuard therapy and successful results from two cases where Japanese physicians used RenalGuard to prevent contrast-induced acute kidney injury (CI-AKI).
The clinical study is designed to assess the ability of RenalGuard therapy to reduce the incidence of CI-AKI in at risk patients, compared to the expected rate of CI-AKI.
A total of 60 patients with pre-existing kidney dysfunction that are undergoing a catheterization procedure using contrast dye will be enrolled in this clinical trial that will be conducted at two sites.
Combined incidence of CI-AKI and serious in-hospital therapy-related adverse events compared to the expected rate based on the patients' risk factors makes the primary endpoint.
PLC Medical Systems president and CEO Mark R Tauscher noted the company is very excited to begin clinical studies with RenalGuard in Japan.
"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," Tauscher added.
"Once the study is concluded, the results will be submitted to the Japanese MHLW as part of a package for shonin approval from the agency. Completion of this process, if successful, would allow the importation of RenalGuard for sales and marketing in Japan."
RenalGuard has already received CE Mark approval and the company is distributing the device in Europe.