May/June 2018: News Briefs

Relypsa Research Grants Awarded to Three Institutions

In a press release in April, Relypsa, a Vifor Pharma Group company, announced the presentation of three research grants to supplement institutional funding for nephrology and/or cardiology fellows who are researching hyperkalemia and other disorders. Alain Romero, PhD, PharmD, Relypsa vice president of medical and scientific affairs, said, “Our research grants aim to improve patient care, encourage disease awareness, and educate healthcare organizations and professionals. We are excited for the recipients of the Relypsa Nephrology and Cardiology Research Grant Program and look forward to seeing the results of their research.”

The grants will fund research in areas key to improving care for patients with kidney and heart disease: (1) defining the frequency of hyperkalemia in solid organ transplant recipients and correlating episodes of hyperkalemia to clinical episodes; (2) exploring the influence of levels of potassium and urea on fibrosis in animal models of renal dysfunction; and (3) following patients prospectively at a single site who require either a renin angiotensin system blocker and/or a mineralocorticoid receptor antagonist to improve blood pressure and/or cardiac function.

The grants were awarded to the University of Cincinnati, Emory University, and the University of Chicago.

 

Corporate Charitable Foundation Launched by Fresenius Medical Care North America

In April, Fresenius Medical Care North America announced the launch of the Fresenius Medical Care Foundation. According to a press release, the foundation is a “nonprofit created to address the environmental, social, and economic conditions that increase the risk for chronic kidney disease (CKD).” The foundation will be funded by match donations from Fresenius employees, medical staff, and other individuals up to $1 million in its inaugural year.

In the press release, Bill Vale, chief executive officer of Fresenius Medical Care North America, said, “We strive to treat the whole patient—not just for their condition—and recognize the unique role we can play in furthering the national dialogue around chronic kidney disease and transplant awareness. When we look outside the walls of our dialysis clinics, we know we must help people at risk for developing kidney disease and our new foundation is a significant step toward that important, long-term goal.”

As part of the foundation’s first year, Fresenius employees assembled 4000 Health Eating, Active Lifestyle kits that were distributed to school students in Chicago; in addition, the foundation will donate $50,000 to the YMCA of Chicago to support Camp Duncan, a medical summer camp program for children with diabetes and kidney disease.

Kim Sonnen, senior vice president and payer relations and communications at Fresenius Medical Care North America and chairperson of the foundations’ board of directors, said, “Our goal is to get ahead of the curve to create a healthier generation of adults., If we begin promoting a healthy, active lifestyle early in life, we may be able to reduce the prevalence of kidney disease…starting education at a young age is central to the mission of our foundation.”

 

Study Results Reported at Annual Dialysis Conference

At the Annual Dialysis Conference in Orlando, Florida, March 3-6, results of a study conducted in Canada were reported. Manish M. Sood, MD, led the study that found that patients with end-stage renal disease due to autosomal polycystic kidney disease (ADPKD) are significantly more likely to receive a kidney transplant and to use home hemodialysis, compared with patients without ADPKD. Survival rates of patients with ADPKD are also higher, according to an article in Renal and Urology News.

Compared with non-ADPKD patients, those with ADPKD had 7-fold greater odds of undergoing pre-emptive kidney transplantation, 2.4-fold greater odds of undergoing any kidney transplantation, and 2.7-fold increased odds of using home dialysis. In addition, the mortality rate during the 12 years of the study period in the ADPKD group was 21% compared with 34.1% among patients without ADPKD. The lower mortality rates were seen regardless of whether the initial ESRD treatment modality was intermittent hemodialysis (26.8% vs 39%) or peritoneal dialysis (17.4% vs 24.7%).

 

Jynarque™ Is First FDA-Approved Treatment for ADPKD

Jynarque™ (tolvaptan) has received approval from the US FDA as the first treatment to slow decline in kidney function in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Otsuka Pharmaceutical Co., Ltd., manufacturers of tolvaptan, made the announcement of FDA approval in a press release in April.

AKPKD is a progressively debilitating and painful disorder in which fluid-filled cysts develop in the kidneys over time. The cysts enlarge and impair the kidney’s ability to function normally, leading to kidney failure in most patients. ADPKD is diagnosed in approximately 140,000 patients in the United States, and parents have a 50% chance of passing the disease on to each of their children.

Tolvaptan’s efficacy was demonstrated in two trials: the 1-year REPRISE study and the 3-year TEMPO study. In both trials, decline in kidney function was slowed in adults at risk for rapidly progression ADPKD receiving tolvaptan.

In the Otsuka press release, Michal Mrug, MD, investigator on the REPRISE trial said, “The progressive nature of ADPKD means that kidney function gets worse over time, eventually leading to end-stage renal disease…Todays’ approval is great news for adults at risk for rapidly progressing ADPKD because by slowing the decline in kidney function, this therapy may give them more time before kidney transplant or dialysis.”

 

Fresenius Kidney Care Announces Five-Star Ratings Success

Fresenius Kidney Care, a division of Fresenius Medical Care North America, and one of the leading networks of dialysis facilities in the United States, issued a press release announcing that it achieved the highest results in the industry as a result of the government’s Five-Star Quality Rating System. The scores are based on the Five-Star Quality Rating System by the Centers for Medicare & Medicaid Services based on a series of measurements of clinical performance and patient outcomes.

Ron Rodgers, executive vice president of Fresenius Medical Care North America and president of Fresenius Kidney Care, said, “Our Five-Star success demonstrates our commitment to the highest quality of patient care. These results are a testament to our family of caregivers and physicians across the US who are the foundation of our five-star quality.”

The ratings represent the fourth consecutive year that Fresenius Kidney Care had a significant increase in the percentage of clinics achieving a rating of five out of five stars; 659 of Fresenius clinics achieved the highest rating.

Jeffrey Hynes, MD, chief medical officer for Fresenius Kidney Care, said, “This recognition is a direct result of our dedicated staff who work every day to improve the lives of our patients. The Five-Star rankings reflect our success in reducing hospitalizations, infections, and other key quality measurement reflected in the ratings. Our disciplined approach to quality is key to our ongoing success.”

 

Late-Breaker

Veltassa® Supplemental NDA Approved by FDA

In early May 2018, Veltassa® (patiromer) received FDA approval of a supplemental New Drug Application (sNDA) for use with or without food. According to a May 8 press release from Relypsa, a Vifor Pharma Group company, the label approval was effective immediately for the treatment of patients with hyperkalemia.

“Since the US approval of Veltassa two years ago, we have seen how the availability of this medicine has been able to significantly transform the way physicians treat hyperkalemia. We are pleased with the FDA’s approval of this supplement and believe the updated label will provide patients with greater flexibility in incorporating Veltassa in their daily treatment regimen,” said Scott Garland, president of Relypsa.

An estimated 3 million individuals in the United States with stage 3 or 4 chronic kidney disease and/or heart failure have hyperkalemia, defined as elevated levels of blood potassium. Hyperkalemia increases the risk of abnormal heart rhythms and sudden death. Some patients with CKD taking medications to delay progression of their underlying disease may experience hyperkalemia as a side effect.  Such medications include renin angiotensin aldosterone system inhibitors (i.e., angiotensin receptor blockers, aldosterone antagonists, and angiotensin-converting-enzyme inhibitors).

The label update was based on results from the phase 4 TOURMALINE study. Results demonstrated that there was no statistically significant difference in achieving the study end point between a group taking Veltassa with food and a group taking it without food.

TOURMALINE randomly assigned 114 patients with blood potassium >5.0 mEq/L to receive once-daily Veltassa at a starting does of 8.4 g either with or without food. Overall, 87.3% of the with food group and 82.5% of the without food group achieved potassium levels in the target level range (3.8-5.0 mEq/L) at either week 3 or week 4. In general, patients with higher levels of potassium had greater reductions in potassium. In multivariable analysis adjusting for baseline potassium, race, estimated glomerular filtration rate, and type 2 diabetes, results were consistent.