NIH Funds $17 Million Studies On Arthritis Drug For Kidney Transplants
By Cyndi Root
The University of California at San Francisco (UCSF) announced in a press release that it is the lead institution in a 7-year, $17 million study of the rheumatoid arthritis (RA) drug tocilizumab to treat kidney transplant recipients. Other participating institutions funded by the National Institutes of Health (NIH) grant are the University of Alabama at Birmingham, Emory University, and Cedars-Sinai Medical Center.
Flavio Vincenti, MD at UCSF, the principal investigator of the study, said, “This grant allows us to work toward achieving two important advances in the transplant field. We can introduce personalized medicine by treating patients based on molecular profiling of their kidney. We also can allow control of the response to the transplant by the patients’ own immune systems by regulatory T cells, either through infusions or pharmacologically.”
NIH Multicenter Study
The new NIH multicenter study seeks to prolong kidney survival in transplant patients by reducing or eliminating inflammation and associated decline. Biologists and mechanistic researchers will conduct two clinical trials seeking to improve long-term graft success. Currently, due to tubular atrophy and interstitial fibrosis, complete loss of kidney occurs at an annual 4 percent rate. The transplant centers selected for the study have a high volume of kidney transplants and the infrastructure and personnel to recruit and conduct the studies.
Two Clinical Trials
Improving the long-term transplant success rate hinges on reducing the inflammatory response. Therefore, the NIH study will conduct two trials. One trial seeks to increase the activity of T cells (Tregs) by infusion. Normally, these Tregs help maintain the immune system and can be used to control transplant rejection. They can also be used to induce a desired immune response in transplant patients.
The second trial, TRAIL (Therapy to Reduce Allograft Inflammation with IL6 inhibition), will use Roche’s and Chugai’s tocilizumab to block interleukin 6 (IL6). Tocilizumab is a humanized anti-IL-6 receptor monoclonal antibody, approved in the U.S. for RA. Due to data from preclinical and clinical studies, researchers seek to investigate IL6’s role in mediating chronic organ injury. RA studies have shown a significant increase in Tregs after treatment with tocilizumab.
Roslyn Mannon, M.D. and lead investigator at the University of Alabama at Birmingham (UAB), said in the University’s press release that she expects trials to begin in the fall of 2014. She added that UAB has 27 patients already enrolled and the other sites have enrolled 65 transplant patients.