Compared with cyclosporine, ISATX247 significantly prolongs renal-allograft survival in a nonhuman primate model

Transplantation
Clare R GregoryRandall E Morris

Abstract

ISATX247 is a novel calcineurin inhibitor that has shown more potency than cyclosporine in vitro. This is the first study to compare the survival times of renal allografts in nonhuman primates treated with either ISATX247 or cyclosporine. Adult, male cynomolgus monkeys were divided into blood-group compatible and mixed-lymphocyte, stimulation-mismatched, donor-recipient pairs. Heterotopic renal transplantation and bilateral native nephrectomies were performed. The monkeys were placed into either an ISATX247 or cyclosporine treatment group. Both groups were dosed twice daily to maintain a 12-hour drug-trough level of 150 ng/mL. Whole-blood concentrations of ISATX247 and cyclosporine, complete blood counts, and serum chemistry profiles were performed three times a week. Euthanasia was performed if the serum creatinine concentration became 7 or more mg/dL or a serious complication developed. The group receiving ISATX247 (n=8) survived significantly (P=0.0036) longer than the group receiving cyclosporine (n=7). The mean trough blood concentration of ISATX247 was 120 +/- 32 ng/mL and cyclosporine was 189 +/- 130 ng/mL. The average area under the curve 0-12 for ISATX247 was 6045 +/- 1679 ng/mL/hr and for cyclosporine was 4919 +/- 823...Continue Reading

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Citations

Jan 20, 2011·Acta Crystallographica. Section D, Biological Crystallography·Andreas KuglstatterMichael Hennig
Aug 19, 2008·Investigative Ophthalmology & Visual Science·Matthew A CunninghamRobert B Nussenblatt
Oct 4, 2011·Clinical Ophthalmology·Martin RoeselCarsten Heinz
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Apr 19, 2005·Expert Opinion on Investigational Drugs·Anamaria Jorga, Atholl Johnston
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May 24, 2013·Ophthalmology and Eye Diseases·Clyde Schultz
Aug 24, 2012·World Journal of Transplantation·Hari Varun Kalluri, Karen L Hardinger
Jul 30, 2020·Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics·Jehan AlamStephen C Pflugfelder

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