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news.Isotechnika has begun enrollment in a North American phase IIb kidney transplant trial for its lead immunosuppressive drug, ISA247.
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The overall goal of the trial is to find the most appropriate dose that will result in efficacy with minimal side effects that are typically seen with other calcineurin inhibitors such as cyclosporine and tacrolimus.
The primary endpoint of the trial is defined as non-inferiority in rejection episodes in patients receiving ISA247 for six months as compared to the control group that will receive tacrolimus, an alternative immunosuppressant drug.
Additionally, kidney function and other laboratory parameters such as hypertension, hyperlipidemia and new onset diabetes mellitus will be monitored for the duration of the trial.
The trial will be performed at thirty-four centers across North America, including twenty-nine centers in the US and five centers in Canada. A total of 332 newly transplanted kidney transplant patients will be enrolled in this trial.
“We are excited to move ISA247 forward in the area of transplantation as well as for the treatment of psoriasis,” stated Dr Randall Yatscoff, Isotechnika’s president & CEO.