Clinical Studies on Renal Transplantation

Newer Immunosuppressive Therapy and Prevention of Cardiovascular Diseases

Barbara A. Bresnahan, MD, Brahm Vasudev, MD, Ehab R. Saad, MD, FACP, FASN, MA and Liliana Osadchuk, MD, have been involved in a number of pharmaceutical and NIH-sponsored clinical studies in the kidney transplant field.

  • There have been two studies looking at newer formulations of previously approved transplant medications including Myfortic (Novartis) and MR4 tacrolimus (Astellas). The aim of these studies was to look for decreases in side effects and ease of administration to increase compliance.
  • Newer, novel biological agents such as Belatacept instead of calcineurin inhibitor such as Cyclosporine are being investigated. Calcineurin inhibitors have been the backbone of immunosuppressive regimes for 20 years but are known to be toxic to the kidney. Belatacept, a fusion protein of CTLA4 and human IgG, binds to CD 80/86 receptors blocking T cell interaction. Used in studies in place of calcineurin inhibitors it also offers unique dosing by intravenous administration every 4 to 8 weeks that will hopefully increase compliance.
  • CP-690,550, a JAK3 inhibitor, is under phase 2 investigations in comparison with a standard calcineurin inhibitor. It is anticipated that CP-690,550 will have fewer nephrotoxic effects since the agent's target, Janus Kinase 3, is restricted to cells in the immune system and is a new class of immunosuppression with a potential role in organ transplantation.
  • FK778 is a metabolite of leflunomide, an FDA approved medication used to treat rheumatoid arthritis. FK778 is thought to have antiviral activity as well as immunosuppressive effects in conjunction with tacrolimus in new renal transplant recipients. Since many transplant recipients suffer from a variety of viral infections (CMV, EBV and polyoma) FK778 might offer potential advantages over standard therapy.
  • A NIH-sponsored study, Folic Acid for Vascular Outcomes Reductions in Transplantation (FAVORIT), is being performed at MCW. This study is looking at the role of homocysteine reduction with folic acid and vitamins B6 and B12 in the incidence of cardiovascular disease in kidney transplant recipients.
  • Genomics for Kidney Transplantation is an NIH program project grant founded at Scripps Research Institute. This study is developing technologies for gene expression profiling, proteomics and complex trait genetics in advancing the understanding of kidney transplantation in both its basic biology and clinical application. Acute rejection and chronic allograft nephropathy are important initial entities to be studied.

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Page Updated 05/16/2015