A review of research, drug approvals for the kidney-care community in 2012

While dialysis providers worry about the ESRD Quality Incentive Program, CROWNWeb, and the potential impact of the "fiscal cliff" on the ESRD payment bundle, I wanted to highlight some of the biggest research stories posted on NephrologyNews.com in 2012.

Kidney community cuts first-year dialysis mortality by 12%
The headline says it all. The U.S. dialysis community has seen very little progress in cutting first-year dialysis mortality over the years, so the results of a three-year effort led by Kidney Care Partners is encouraging. With six months of data reporting through December 2012 still remaining, the PEAK (Performance Excellence and Accountability in Kidney Care) initiative may come closer to its 20% goal, but the Brown University data analyst who tracked the effort called the 12% drop "pretty substantial."

FDA approves Affymax's peginesatide to treat anemia in dialysis patients
New drug approvals for kidney disease patients are rare these days, so this story was a headline grabber. Omontys is the first FDA-approved drug to be marketed in the United States to treat anemia in dialysis patients in 20 years. To date, Takeda and Affymax have contracted with six dialysis providers, including Fresenius Medical Care, DSI Renal, and U.S. Renal Care.

Earlier endpoints proposed for chronic kidney disease trials
The U.S. Food and Drug Administration is now considering new endpoints for clinical trials in chronic kidney disease patients as a result of a special scientific workshop convened by the National Kidney Foundation in December. Prior to this workshop, halving of GFR, assessed as a doubling of serum creatinine levels, was considered an acceptable surrogate endpoint for the development of kidney failure.

"Yet while doubling of serum creatinine is predictive of kidney failure, even this takes a long time to develop," said workshop co-chair Andrew Levey, MD, Professor of Medicine, Tufts Medical Center. "That's why NKF collaborated with the FDA on this initiative to identify alternative endpoints that could potentially shorten the duration of clinical trials and extend their application to the early stages."

Updated chronic kidney disease guideline aims to help physicians more accurately predict prognosis
The new guideline, published in Kidney International Supplements, retains the current chronic kidney disease definition but augments the classification system to include albuminuria, or protein in the urine, and cause of disease, as well as GFR stage.

Researchers gain better understanding of kidney inflammation
In a study published Dec. 17 in Nature Medicine researchers used advanced microscopy techniques to visualize the movements of leukocytes through the kidney. Leukocytes play protective roles in the body's immune system, but for patients with glomerulonephritis they cause damaging inflammation and lead to end-stage renal disease.

"In order to manipulate a system, you must understand it. Now, we have a really clear understanding of the disease process and the molecules involved in the key steps," said lead researcher, Michael Hickey

Study shows benefit for ADPKD patients who take Tolvaptan
The renal community must remain cautious in their optimism, but the treatment implications of this could be big. "This is the first time that a drug specifically targeted to alter ADPKD progression in humans has been shown to be of benefit," said Jared Grantham, MD, the founder of the PKD Foundation and co-author of the research paper.

Circulating blood factor linked with a leading cause of kidney failure
Patients with focal segmental glomerulosclerosis tend to have high levels of a particular factor circulating in their blood, according to a study published in the Journal of the American Society of Nephrology. It might also be a therapeutic target of future treatments for this difficult-to-treat disease.

Diabetes research

Study links high fructose corn syrup use to diabetes
A new study by University of Southern California (USC) and University of Oxford researchers reports that countries that use high fructose corn syrup in their food supply had a 20% higher prevalence of diabetes than countries that did not use the sweetener.

The overwhelming rise in diabetes in this country is having a devastating effect, and leads to an increase in kidney failure. Understanding why the prevalence of the metabolic disease has increased so dramatically is necessary for prevention. There are obviously many variable at play, and this appears to be one of them.

National Kidney Foundation updates KDOQI diabetes guideline
More aggressive glycemic control that was once recommended is not appropriate for all patients, according to the new update of the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) Clinical Practice Guideline for Diabetes and Chronic Kidney Disease. This represents a fundamental shift in how diabetes is treated.

"The 2012 update primarily refines the previous guideline and we believe it carries a critical message – more is not always better,” said KDOQI guideline co-chair, Katherine Tuttle, MD, Medical and Scientific Director of Research at Providence Medical Research Center in Spokane, Washington.

Researchers find new target to treat diabetic kidney disease
Like most research, it could take years before any new treatment arises from this study, but it brings us one step closer to understanding the mechanisms behind diabetic nephropathy and inflammation. -by Rebecca Zumoff

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