July/August 2018: News Briefs

Lori Neal and Kevin Harris Named to NNCC Board of Commissioners

Lori Neal, BSN, RN, CNN, and Kevin Harris have been appointed to the Board of Commissioners of the Nephrology Nursing Certification Commission (NNCC). In a June press release, NNCC announced that Ms. Neal and Mr. Harris will serve 2-year terms.

Ms. Neal is a clinical support specialist for Fresenius Medical Care from Plain City, Utah. She has experience in acute therapies, outpatient setting, and management, and brings nearly 20 years experience to her new position. Since 2016, she has been a member of the NNCC Board and has held Certified Nephrology Nurse credentials for 13 years. She is pursuing her MSN degree.

Mr. Harris, a financial advisor for Edward Jones from Deep River, Connecticut, is a member of the US Chamber of Commerce and a member of several other professional boards. His role of the NNCC board will be that of Public Member.

NNCC is a certifying organization that establishes credentialing mechanisms to promote patient safety and to improve the quality of care provided to nephrology patients, according to the press release.


FDA Grants Clearance to ClearGuard HD Caps for Broader Indication

The US FDA has granted clearance for a broader indication of ClearGuard® HD Antimicrobial Caps (Pursuit Vascular, Inc., Maple Grove, MN), to include reduction in the incidence of central-line associated bloodstream infections in hemodialysis patients with central venous catheters. ClearGuard HD caps were initially cleared for use with hemodialysis catheters in 2013. Post-market clinical surveillance data influenced the expanded clearance.

The ClearGuard HD cap is the first and only device cleared for sale in the United States that kills infection-causing bacteria inside a long-term hemodialysis catheter. The caps have been clinically shown to reduce central line-associated bloodstream infection and carry seven issued US patents, with several others pending.

In a press release from Pursuit Vascular, Doug Killion, president and CEO, said, “Bloodstream infections can have a devastating effect on patients and contribute significantly to healthcare costs for insurers and patients. Dialysis patients are particularly vulnerable to infections, and ClearGuard HD caps represent a lifesaving tool that has a real impact on these patients’ lives.”

In a second press release, Pursuit Vascular announced the publication of study results in the Journal of the American Society of Nephrology conducted by DaVita Clinical Research demonstrating that the use of ClearGuard HD caps resulted in 63% lower bloodstream infection rate compared with use of the Tego Connector in combination with Curos cap. The 13-month, prospective, multicenter, cluster-randomized trial included 1671 patients accruing ~183,000 treatment-days at 40 dialysis centers across the United States.

“These findings represent an important advancement in hemodialysis care for patients who are receiving dialysis, The ClearGuard HD cap is a first-of-its kind device, and these results demonstrate that it provides a clear and significant benefit to patient health,” Mr. Killion said.


Organ Transplant Recipients Practice Sun Protection after Skin Cancer Study

In a research letter in JAMA Dermatology, Rebecca I. Hartman, MD, MPH, and colleagues reported a significant increase in the number of organ transplant recipients who practiced multiple sun protection behaviors following participation in a skin cancer research study for at least 1 year without any specific educational intervention. The retrospective study included kidney and liver transplant recipients at high risk of skin cancer. Use of multiple skin protection measures was defined as use of at least two of these practices >50% of the time when outdoors.

“We found that the use of multiple sun protection behaviors increased among organ transplant recipients after participation in a skin cancer research study. Future research is needed to quantify the longer-term clinical consequences of skin cancer–focused clinics on skin cancer-association morbidity and mortality among organ transplant recipients,” the researchers concluded.


Standford Health Care Dialysis Unit Receives NNCC Advocacy Award

The Nephrology Nursing Certification Commission (NNCC) has selected the Standford Health Care Dialysis Unit as the recipient of the 2018 Advocacy Award. The award is presented for outstanding performance in advancing nephrology nursing certification and patient care. Standford Health Care Dialysis Unit is part of the Kidney Clinic in Palo Alto, California, that specializes in “comprehensive care and treatment for kidney disorders, including amyloidosis, polycystic disease, renal insufficiency, and kidney failure,” according to a press release from NNCC.

Pedram Fatehi, MD, MPH, medical director of inpatient dialysis services at the Standford Unit said, “Our dialysis nurses constantly maintain excellence in patient care. This culture of continuous improvement is exemplified by the priority they [the dialysis nurses] place on formal nursing certification.”

The NNCC launched the Advocacy Award in 2014 to recognize organizations advocating or promoting certification in nephrology nursing and to spotlight organizations that demonstrate the value of nephrology nursing certification to promote safety and improve quality patient care. The 2018 award was presented by Kim Alleman, MS, APRN, FNP-BC, CNN-NP, NNCC president during an award ceremony on May 14. The Standford Unit received a plaque and a $500 gift card during the ceremony.


Rates of Hospice Enrollment Low among Medicare Beneficiaries

In general, Medicare patients on maintenance kidney dialysis follow one of four paths of healthcare expense and intensity in their last year of life, according to results of a recent study reported in the journal Health Affairs. The study was designed to examine whether varying patterns of care exist within that patient population. The study cohort included 640,000 patients with end-stage renal disease ages 18 to 100 years who died between 2000 and 2014.

The researchers found four distinct groups that followed different paths to the end point of death: (1) group 1 (9%) had escalating spending during all four quarters in the year preceding death; (2) group 2 (41%) had relatively low spending for three quarters, with escalation in the last quarter; (3) group 3 (37%) had moderate spending for three quarters, with escalation in the last quarter; and (4) group 4 (13%) had persistently high spending during all four quarters.

For all groups, fewer than one in four patients enrolled in hospice; in the general Medicare population, the hospice-enrollment rate is nearly 50%. In all four groups, patients spent a median of 5 to 6 days in hospice; again, far less than other Medicare beneficiaries.

Several care models that may be adapted to more flexibly provide hospice and palliative care for patients on dialysis are being tested by the Center for Medicare and Medicaid Innovation, according to Ann O’Hare, MD, lead author of the report.


Humacyte and Fresenius Medical Care Announce Global Partnership

In a press release in June, Fresenius Medical Care and Humacyte, Inc., announced a strategic, global partnership and a $150M USD equity investment. Fresenius Medical Care is the world’s largest provider of dialysis products and services and Humacyte is a medical research, discovery, and development company.

According to the press release, the agreement has “the potential to make Humacyte’s novel human tissue-based product, HUMACYL®, available to more patients worldwide following approval.” HUMACYL is being evaluated for vascular access for hemodialysis; the product may be more effective than current synthetic grafts and fistula. Under the terms of the agreement, Fresenius Medical Care will obtain exclusive global rights to commercialize HUMACYL.

Franklin Maddux, MD, chief medical officer for Fresenius Medical Care North America, said, “By partnering with Humacyte, Fresenius Medical Care has an opportunity to offer a dialysis vascular access option with the potential for significant clinical efficacy and safety improvements, including the potential to minimize catheter contact time to the benefit of our patients. Our exclusive rights to distribute this innovative technology to dialysis patients worldwide may have significant benefits not only to patients, but health systems as well. With the potential for fewer anticipated complications and interventions compared to synthetic grafts, we may see increased safety for patients and reduced medical and economic burdens to the healthcare system.”

Carrie Cox, CEO and chairman of Humacyte, Inc., said, “Our partnership will allow Humacyte to focus on advancing the potential for HUMACYL as a substantial breakthrough in the science of regenerative medicine, and to continue our development of an exciting future pipeline.”

Humacyte’s bioengineered blood vessel is in phase 3 pivotal trials in the United States and Europe; the company will seek regulatory approval in both regions upon completion of the trials.


Enrollment Complete in Trial of Obinutuzumab for Lupus Nephritis

In mid-June, Genentech announced completion of enrollment for a phase 2 clinical trial investigating the safety and efficacy of obinutuzumab, a CD20-directed cytolytic antibody, for adults with lupus nephritis. NOBILITY, a phase 2, randomized, double-bind, placebo-controlled, multi-center study comparing the safety and efficacy of obinutuzumab with mycophenolate (MMF)/mycophenolic acid (MPA) and corticosteroids with placebo combined with MMF/MPA and corticosteroids in patients with ISN/RPS 2003 Class III or IV proliferative lupus nephritis.

Up to 60% of patients with systemic lupus erythematosus will develop lupus nephritis, a potentially life-threatening inflammation of the kidneys; of those, up to 25% will develop end-stage renal disease.

Jeffrey Siegel, MD, global head of rheumatology and rare diseases at Genentech, said, “Now that we have completed enrollment, we are focused on continuing our research with the hope that we can deliver an impactful therapeutic option for this serious, potentially life-threatening condition for which there are currently no FDA-approved medicines.”