Comparison of Sandimmun with a new cyclosporin derivative (IMM 125) in renal transplant patients with stable renal function. IMM 125 Multicentre Study Group.

A double-blind switch-over study was carried out on 70 renal transplant patients to assess the value of a new cyclosporin derivative, IMM 125. Preclinical in vitro and in vivo studies indicated that IMM 125 was as equally immunosuppressive as Sandimmun, but that its therapeutic index should be superior. The duration of the treatment was 24 weeks. The assumption that the dosage of IMM 125 could be 2.5 times lower than Sandimmun proved to be false; three patients suffered acute rejection episodes, probably as a consequence of the low dosage, and dosage adjustments had to be made for all patients receiving IMM 125 after only a few weeks. Although IMM 125 is an effective immunosuppressive agent, it does not appear to offer advantages over Sandimmun with regard to renal function. In addition, IMM 125 causes some disturbances in liver function.