Clinical trials begin for feline CKD product

The Japanese company behind an oral treatment for feline chronic kidney disease (CKD) has started clinical trials as it seeks to launch on the European market.

Toray Industries’ product Rapros, which contains the active substance beraprost, has a 70% share of the market in Japan for CKD veterinary treatments.

Beraprost has a vasoprotective effect, which the company claims is “unique and completely different from renin–angiotensin inhibitors”.

The product was approved in 2017 by the Ministry of Agriculture, Forestry and Fisheries of Japan for treatment of kidney function decline and clinical symptoms of International Renal Interest Society CKD stage 2 and 3, having been shown to be clinically beneficial by a randomised controlled trial and a retrospective study.

European approval

Now, a clinical trial is underway in Europe to support the application for a marketing authorisation for the EU.

A randomised, placebo-controlled trial involving 300 cats with CKD will evaluate the safety and efficacy of Rapros.

Toray started the trial after meetings with the European Medicines Agency’s Committee for Veterinary Medicinal Products, and after gaining EU marketing authorisation, will apply to the VMD for the UK.

Vet and study investigator Tamas Jando, clinical director of DélBudavet Veterinary Clinic in Budapest, said: “Today, there is an opportunity in Hungary to join a unique and groundbreaking programme in this field.

“The programme lasts for six months, during which the animal’s quality of life and health data are fully monitored to ensure a pet’s safety to the highest degree possible.”