July/August 2017: News Briefs

KDIGO Issues Updated Guidelines for Treatment of CKD-MBD

In late June, the Kidney Disease Improving Global Outcomes (KDIGO) updated its Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). The update amends the 2009 KDIGO Clinical Practice Guideline and includes revised positions on standards of care for the treatment of secondary hyperparathyroidism (SHPT) in patients with CKD stage 3 or 4.

Therapies with calcitriol and (1a-hydroxylated) vitamin D are no longer suggested for routine use. Under the new guidelines, those therapies should be reserved to patients with CKD stage 4 or 5 with severe, progressive hyperparathyroidism. According to the guideline, recent randomized clinical trials of calcitriol and its analogs did not result in improvement in outcomes, but did demonstrate increased risk of hypercalcemia. KDIGO said the risk-benefit ratio was no longer favorable for routine usage in patients with CKD stage 3 or 4. In addition, supplementation of nutritional vitamin D with ergocalciferol or cholecalciferol has not been proven as effective treatment for SHPT.

The updated guideline acknowledged extended release calcifediol (Rayaldee®) as a novel vitamin D prohormone, noting that it increased serum levels of 25-hydroxyvitamin D and lowered PTH in patients with stage 3 or 4 CKD. Rayaldee is the first and only extended-release prohormone approved by the FDA to treat SHPT; its safety profile is similar to that of placebo.

In a press release from OPKO Health, developers of Rayaldee, Michael J. German, MD, said, “The updated guideline represents a needed shift in the way nephrologists managed secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease. SHPT is one of the most common complications of CKD, and, unfortunately, it has also been historically difficult to treat due to a lack of an effective and appropriate FDA-approved treatment option. Having this updated guidance and the availability of an option like Rayaldee are significant advancements for both patients and providers managing this complex disease.

Charles W. Bishop, PhD, CEO of the OPKO Health Renal Division, said, “The updated KDIGO guideline highlights the unmet needs that exist in the treatment of SHPT, and we are working with physicians and other healthcare professionals to address these needs with Rayaldee.”

Educational Partnership between Cricket Health and American Kidney Fund

Cricket Health and the American Kidney Fund (AKF) have announced a collaborative initiative to provide education and support to patients with advanced stage chronic kidney disease (CKD) and end-stage renal disease (ESRD). One hundred individuals in AKF’s patient network will voluntarily enroll into Cricket Health’s online kidney care platform. Those 100 patients represent the initial group of program participants; Cricket Health is refining the program for a wider commercial rollout to providers and health plans who are looking for an education and care management program for patients with CKD and ESRD.

In a dual press release, LaVarne A. Burton, president and chief executive officer of AKF, said, “As organizations deeply committed to the best health outcomes for the patients we serve, AKF and Cricket Health are logical partners in helping bring technology and patients together. Cricket Health’s platform is a great complement to the patient-focused programs and services we provide.”

Vince Kim, co-founder of Cricket Health, said, “The lack of timely and comprehensive CKD education represents an enormous missed opportunity to increase rates of home dialysis therapies and kidney transplantation among eligible patients. We are excited to work with a leading advocate like the American Kidney Fund to enhance the quality of life for these patients and demonstrate a better way to provide patients the tools and resources necessary to make enduring decisions about the care and management of their disease.”

Chronic Kidney Disease Affects 15% of US Population

The National Kidney Foundation issued a press release highlighting results of a Centers for Disease Control and Prevention study analyzing data from the 2011-2014 National Health and Nutrition Examination Survey and the Chronic Kidney Disease (CKD) Epidemiology Collaboration equation. The study found that the number of Americans affected by CKD is higher than previously estimated; CKD affects 15% of the adult population in the United States.

Kevin Longino, NKF Foundation CEO and a kidney transplant patient, said, “Thirty million Americans are affected by chronic kidney disease and most do not even know they have it. Additional federal resources must be allocated towards increasing public awareness about the disease and advancing programs targeted towards prevention and early detection.”

Other findings included in the release reveal that women are more likely than men to be affected by CKD (16% vs 13%); however, men are more likely than women to progress to end-stage renal disease (ESRD). Approximately 15% of Hispanics have CKD and Hispanics are 35% more likely to progress to ESRD compared with non-Hispanics. CKD is also estimated to be more common in non-Hispanic blacks than in non-Hispanic whites (18% vs 13%).

National Kidney Foundation and HealthUnlocked Announce Online Partnership

In late June, the National Kidney Foundation (NKF) and HealthUnlocked, a website that increases patient engagement to improve health outcomes, announced a collaboration that includes four new online communities providing help, support, and information to people with, at risk for, or affected by kidney disease. The communities will provide support and information on kidney disease, dialysis, living donors, and transplant recipients.

The chief medical officer of HealthUnlocked, Matt Jameson Evans, MD, said in a NFK press release, “Support, help, and information is invaluable to people living with kidney disease or at risk of developing it. This new collaboration will create a safe space for people to ask questions, and reach out to others. By coming to one of these communities, the millions of people affected by kidney disease will find important support from others going through similar experiences.”

Kathryn Pucci, senior vice president, education and programs, at NKF, added, “We are pleased to announce the launch of NKF’s online communities: Early Stage CKD, Dialysis, Transplant, and Living Donation in collaboration with HealthUnlocked. Offering patients and their families a safe outlet to share information, successes, and concerns is at the heart of NKF’s mission.

Agreement to Provide Vadadustat to US

Akebia Therapeutics, Inc., and Vifor Pharma Group announced an exclusive license agreement to market vadadustat to Fresenius Medical Care dialysis clinics in the United States upon US FDA approval. Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer in phase 3 development for the treatment of anemia associated with chronic kidney disease.

In a press release from Akebia, Stefan Schulze, president of the executive committee and chief operating officer of Vifor Pharma said, “Vadadustat could represent a significant advancement in the treatment of renal anemia with the potential to establish a new treatment paradigm and overcome the limitations of current therapies for patients with chronic kidney disease…This transaction strengthens the nephrology product portfolio of Vifor Pharma, and is consistent with our ongoing commitment to deliver innovative products that can improve the lives of patients suffering with chronic kidney disease.”

The terms of the agreement call for Vifor Pharma to exclusively distribute vadadustat to Fresenius Medical Care North America for use solely within its dialysis facilities in the United States to meet their need for an HIF-based treatment for anemia associated with CKD.

John P. Butler, president and chief executive officer of Akebia, said, “This agreement provides the opportunity to build greater commercial momentum for vadadustat in the United States rapidly upon launch. We are pleased that Vifor Pharma has selected vadadustat as its exclusive product for distribution to Fresenius Medical Care, one of the largest dialysis providers. We believe that this commitment provides significant further validation of vadadustat’s potential.”