May/June 2017: News Briefs

Fresenius and Humana Announce Model of Care Coordination

Fresenius Medical North American (FMCNA) is joining forces with Humana Inc. in a program designed to improve care and outcomes for Humana’s members with end-stage renal disease. FMCNA, operating through its Fresenius Health Partners mantle, will apply its proprietary model of care coordination aimed at enhancing the ability of patients to obtain the healthcare services needed to address their illness and improve their quality of life.

Patients will be supported by a team of local nephrologists and clinicians working in coordination with the Care Navigation Unit (CNU) at Fresenius. The CNU is a group of specialized nurses and service coordinators who are available 24 hours a day 7 days a week for support and care coordination.

In a press release from Fresenius, William McKinney, president of FMCNA’s integrated care group, said, “Through this partnership, we will positively impact the overall medical care of Humana’s ESRD members who receive treatment within our dialysis centers, and it’s our responsibility to ensure they can access the care they need, when they need it. Ultimately, we believe our coordinated approach to patient care will be a natural extension of Human’s existing platform and can boost their patients’ health outcomes.”

Mark Steffen, MD, medical director at Humana, said, “We strive to help our chronically ill members achieve their optimal health. By working with Fresenius Medical Care to bring this highly specialized program to Humana’s medically fragile members who need it most, we can help them experience more coordinated care that meets their needs and improves both health outcomes and quality of life as they move along their healthcare journey.”

ANNA Releases Third Edition of Contemporary Nephrology Nursing

The American Nephrology Nurses Association (ANNA) has released the third edition of Contemporary Nephrology Nursing. In a press release from ANNA, Sandy M. Bodin, MA, RN, CNN, editor, said, “Contemporary Nephrology Nursing has always been my favorite nephrology nursing text and it was a pleasure for me to manage this third edition. I am pleased that our strategy produced some fresh and innovative chapters. My hope is that Contemporary Nephrology Nursing will be a principal reference for nephrology nurses and will serve as a tool to improve the health outcomes of patients with kidney disease.”

The new edition includes more than 75 contact hours of continuing nursing education, 22 completely updated chapters with evidence-based data, 28 new chapters, a new section on managing comorbidities and complications, an advocacy section, and a section on regenerative medicine and innovations in nephrology nursing.

For more information and to order Contemporary Nephrology Nursing, visit

THEORY Trial Results Presented at Transplant Conference

At the 2017 American Transplant Congress in Chicago, Robert Redfield, MD, presented data from the THEORY trial, an open-label phase 1b study evaluating obinutuzumab, a type two CD20-directed cytolytic antibody, in candidates for kidney transplant, according to a press release.

The study was designed to measure the safety, pharmacokinetics, and pharmacodynamics of obinutuzumab in hypersensitized patients with end-stage renal disease who were awaiting kidney transplantation. In the study population, obinutuzumab was well tolerated and resulted in substantial peripheral B-cell depletion at both study dose levels.

“Emerging experience with obinutuzumab indicates acceptable tolerability in patients with ESRD undergoing desensitization,” the researchers said.

Drug to Treat Lupus Nephritis Shows Promising Results

During the National Kidney Foundation 2017 Spring Clinical Meetings, Aurina Pharmaceuticals, Inc. presented previously unreported results from a phase 2 study on the use of voclosporin for the treatment of lupus nephritis. Patients with lupus nephritis are at risk for renal damage that, left untreated, may result in irreversible tissue damage in the kidney, leading to end-stage renal disease. At present, there are no approved therapies for lupus nephritis.

Samir Parikh, MD, a clinical investigator for the study and assistant professor of clinical nephrology at Ohio State University, presented 48-week results from the AURA study. According to a press release from Aurina, the trial met the end points of complete and partial remission at 48 weeks. In addition, all secondary end points that have been analyzed to date were also met.

Both study doses of voclosporin demonstrated continued improvement compared with the control group at 48 weeks. The voclosporin groups had statistically significantly improved speed and rates of compete and partial remission. Of those in the low-dose voclosporin group who achieved complete remission at 24 weeks, 100% remained in complete remission at 48 weeks. Proteinuria levels and reduction in systemic lupus erythematosus disease activity index scores also continued to significantly separate over time versus the control group.

Additional analyses are ongoing.

Aurina plans to initiate a phase 3 clinical trial (AURORA) in the second quarter of 2017.

Robotic Surgical Removal of Stage IV Tumor Thrombus Successful
A surgical team at Keck Medicine of the University of Southern California (USC) has performed the first robotic, minimally invasive surgical removal of a stage IV tumor thrombus (kidney cancer extending into the heart).

In a press release from USC, Inderbir S, Gill, MD, distinguished professor of urology and founding executive director of the USC Institute of Urology and associate dean of clinical innovation at the Keck School of Medicine of USC, said, “This exciting feat promises to redefine the boundaries of what is surgically possible through skill, collaboration, and technology. Our hope is that we can now propel the field at large to turn such futuristic robotic surgery into our present standard of care.”

The surgery included cardiac and urologic surgical teams that worked together to coordinate the complex efforts required for the surgery. “This was the driver of our success and exactly the standard we strive for across the institution,” Mark Cunningham, MD, associate professor of surgery said.

In 2015, Dr. Gill became the first surgeon to use robotic high intensity focused ultrasound surgical ablation to ablate a kidney tumor. Currently, the USC Institute of Urology has one of the world’s highest volumes of advanced robotic surgeries annually and is a premier worldwide robotic training center, according to the press release.

Early Predictor of Transplant Rejection Detected

Researchers at the Perelman School of Medicine at the University of Pennsylvania have discovered a method that appears to provide warning of rejection of organ transplants sooner than standard current methods. The new method requires only a blood test rather than a more invasive needle biopsy.

According to a press release from the National Institutes of Health, Prashanth Vallabhajosyula, MD, and Ali Naji, MD, transplanted human islet cells into mice. The researchers confirmed that the transplanted islets released exosomes in the animals’ bloodstreams. The exosomes had donor-specific markers on their surfaces that could be used for detection. Levels of donor cell-released exosomes dropped sharply in the bloodstream, and their contents changed, before glucose levels changed in response to tissue rejection.

The findings suggest that exosomes may be useful in detecting transplant injury sooner than current technologies. Dr. Naji said, “I believe that analyses of exosomes released by transplanted organs into the patient’s blood will ultimately provide a very powerful and unprecedented ability to understand the conditional state of the organ as a whole.”