From Houston Chronicle Houston, Texas, By Pam Mitchell
Anthony Lockett has end-stage renal disease. To stay alive, he must undergo dialysis three times a week. Each appointment takes four hours.
A new kidney would eliminate this need and significantly improve his quality of life, but Lockett has yet to near the top of the transplant waiting list despite being on it for more than two years and on dialysis for more than three. Demand for organs far exceeds supply, and his blood type, the rare B, makes a match difficult.
His chance of getting a kidney will increase come mid-December, though, when the United Network of Organ Sharing, or UNOS, as most know it, begins a new allocation system. The changes will make more deceased-donor kidneys available to candidates such as Lockett and will make better use overall of the organs.
"The current kidney allocation system goes back to the mid-'80s. This is the first major overhaul," said Dr. Mark Aeder, transplant surgeon and vice chair of the kidney-transplantation committee for the nonprofit UNOS, which serves as the U.S. Organ Procurement and Transplantation Network under contract with the federal government.
This topic and other organ-donation-awareness efforts will be front and center July 11-15 when the Transplant Games of America comes to Houston. The event brings thousands of organ transplant recipients and living donors to compete in 15 medal events, including basketball, cycling, swimming, tennis and track and field, at venues including BBVA Compass Stadium, Memorial Park and Rice University.
One change in the organ-allocation system's new rules will directly affect Lockett. Currently, candidates with blood type B - the majority of whom are African-American or Asian - generally cannot receive a kidney from a donor with the more common blood type A, unless the donor falls into a certain blood subtype. The new system will give first priority for those kidneys to type B candidates who prove a match.
"I was happy to hear about that change because it will give me a broader donor base," Lockett said. He teaches health-care certification classes to supplement disability payments but would prefer to make better use of theMBA he earned before receiving his diagnosis of kidney disease as a result of a connective tissue syndrome.
Another change involves transplant wait times. UNOS currently looks at when a candidate was listed. The new system will instead use the date on which dialysis began, or other medical criteria were met, when determining placement on the waiting list. Many candidates with serious kidney disease, despite the need, do not immediately register for a transplant.
"Sometimes they are scared and sick and just not ready to consider it," said Dr. Horacio E. Adrogué, Lockett's physician and the medical director of renal and pancreas transplantation at Memorial Hermann-Texas Medical Center.
Patients also may be in a medically underserved area and not offered the option of a transplant.
Other changes to come with the new kidney-allocation system are giving increased priority to candidates who may have donated an organ - any organ - and giving those with immune-system sensitivity improved access to kidneys they are not likely to reject.
However, the biggest and most complex change to come involves factoring in longevity, or survival after the transplant. In the new system, both candidates and deceased-donor kidneys will be scored according to certain criteria. Age, length of time on dialysis, previous transplants and a current diagnosis of diabetes will factor into a candidate's estimated post-transplant survival (EPTS) score.
Age, height, weight, ethnicity, certain causes of death, history of high blood pressure or diabetes, hepatitis C virus exposure and kidney function will factor into a kidney donor profile index (KDPI) score. In the current system, only donor age, history of hypertension, kidney function and certain causes of death are considered when matching.
"The way it works now, someone could come in at age 90 and get the kidney of someone who was 20, and someone who is 20 may get the kidney of someone who was 90, said Adrogué of the importance of life expectancy.
The EPTS and KDPI scores will allow UNOS to match the organs expected to function for the longest time to the candidates who will need them the longest. This also should reduce the number of second transplants needed, which affects organ availability for all. [Read more]
PKD Research
From Pharmaceutical Business Review
Kadmon begins Phase IIa portion of KD020 trial in autosomal dominant polycystic kidney disease
US-based Kadmon has started the Phase IIa portion of a Phase Ib/IIa trial of KD020, the company's orally bioavailable small molecule kinase inhibitor of Src, HER2, EGFR and VEGFR2/KDR, in autosomal dominant polycystic kidney disease (ADPKD).
Start of the Phase IIa portion of the trial follows the unanimous recommendation of the study's Data Safety Committee after their review of all Phase Ib safety and pharmacokinetics data.
The disease is caused by a mutation in either the polycystin 1 or 2 (PKD1 or PKD2) genes, resulting in the abnormal, uncontrolled growth of renal tubular epithelial cells.
ADPKD is characterized by the formation of cysts in the kidney causing destruction of the kidney parenchyma resulting in loss of renal function.
PKD is the fourth highest cause of kidney failure and clinical symptoms usually develop between the ages of 30 and 40, but they can start earlier and include persistent flank pain, hypertension, kidney and urinary tract infections and hematuria.
In the Phase Ib portion of the trial, KD020 was generally well tolerated, with rash (Grade 2) as the most common > Grade 1 adverse event in the highest dose group (150mg daily).
The Phase IIa trial is designed to assess the activity, safety and tolerability of an alternate dosing schedule of 150mg of KD020 administered thrice times weekly.
Kadmon chairman and CEO Samuel Waksal said autosomal dominant PKD is one of the most common life-threatening genetic diseases, frequently leading to end stage kidney disease requiring dialysis or transplant as early as the fourth decade of life.
"Unlike currently used therapies, which address symptoms but do not delay onset to kidney failure, KD020 is designed to inhibit the molecular pathways central to progression of the disease itself, namely EGFR, Src and VEGFR," Waksal said.
"We are encouraged by the initial tolerability profile of KD020, and look forward to understanding its broader potential in addressing ADPKD through the Phase IIa portion of the study."
From University of Michigan Health System
for CKD.
Partly due to an aging and overweight population, chronic kidney disease — a condition in which damaged kidneys cannot filter blood as well as healthy kidneys — is one of the nation’s fastest growing chronic diseases.
“Addressing the initial mechanisms of CKD may be more beneficial and is good news for patients who could receive therapy earlier on for a variety of kidney diseases before they progress into CKD,” says Matthias Kretzler, M.D., a professor of internal medicine and bioinformatics and a nephrologist at the U-M Health System.
CKD affects over 13 percent of the United States population, about 26 million people. Diseases and infections that can damage kidneys and cause CKD include autoimmune disease like lupus leading to glomerulonephritis, polycystic kidney disease or kidney problems people are born with.
However, the most common causes of chronic kidney disease are diabetes and high blood pressure.
Using combined genetic and clinical data, Kretzler, U-M’s Sebastian Martini, M.D., and colleagues revealed a network of shared genetic pathways associated with CKD in a study published online ahead of print in the Journal of the American Society of Nephrology.
The unique methodology helped to describe what the key molecular drivers of CKD are, what CKD-causing diseases were most closely related and to understand specific molecular mechanisms causing the disease to progress or worsen in different patients.
The CKDGen consortium, European Renal cDNA Bank-Kroener-Fresenius Biopsy Bank, and the Clinical Phenotyping Resource and Biobank core contributed to the study.
"The study highlighted why understanding the way different diseases share the same molecular mechanism is important for treatment," says Martini, a systems biologist at the U-M Medical School. [Read more]
PKD Fundraising
Polycystic Kidney Disease is one of the most common, life-threatening genetic diseases affecting thousands in America.
Now there is a new foundation chapter to support PKD in the Tri-State.
Currently, there is no treatment or cure but you can help bring treatment within reach.
The first event for the new Evansville PKD Foundation Chapter is happening on Saturday, June 28.
The foundation is selling tickets to the Otters game.
Each ticket is $5 with $3 going directly to the PKD Foundation.
The event starts at 6:35 p.m. and there will be a fireworks show to follow.
Click here to visit the chapter's Facebook page. You can join the group for future events.
Dialysis News
From Columbus Dispatch, Columbus, Ohio, By Ben Sutherly
Eleven dialysis centers in Ohio have seen their Medicare payments cut this year after receiving low performance scores that were made public recently.
Three of the centers are in central Ohio. Kidney Center of Bexley and DaVita Pataskala Dialysis Center in Licking County each received a 1 percent reduction, while reimbursement for U.S. Renal Care of Delaware was cut by 0.5 percent.
Owners of some of the centers said that their small number of patients put them at a disadvantage in Medicare’s scoring system.
Of nearly 6,000 dialysis centers with Medicare certification nationwide, only 46 received the maximum payment cut of 2 percent, a Dispatch analysis found. Just 20 had a performance score of zero, including Fresenius Medical Care’s Suburban Home Dialysis in Warrensville Heights, a suburb of Cleveland.
This is the third year that Medicare has docked some dialysis centers’ payments because of low performance scores.
The payment cuts are based on performance in 2012. That year, about 370,000 U.S. residents with end-stage renal disease received dialysis under fee-for-service Medicare, according to the Medicare Payment Advisory Commission, which advises Congress on Medicare issues.
Three clinical metrics account for 90 percent of a dialysis center’s overall performance score: a measure for anemia management and hemoglobin levels, which are to be 12 grams per deciliter or lower; a measure of how well dialysis removes waste products from patients’ blood (known as the Urea Reduction Ratio); and a measure based on the type of vascular access used to treat patients (using catheters for dialysis lowers that score).
Reporting measures — such as confirmation that each Medicare patient’s calcium and phosphorus serum levels have been measured each month — account for the remaining 10 percent of the score.
But low numbers of Medicare patients can put some dialysis centers at a disadvantage. If a facility doesn’t have at least 11 eligible Medicare patients for a particular clinical measure, that measure does not count, reducing a score.
The Fresenius Warrensville Heights location, for example, did not have enough eligible Medicare patients for any of its clinical measures to count. Only its reporting of patients’ calcium and phosphorus levels counted toward its score, and the center didn’t fare well on that measurement. [Read more]
