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New Test Helps Detect Kidney Failure - Renal Business Today

MADISON, N.J.—The Renal Transplant Monitoring laboratory-developed test is designed to help physicians detect kidney failure weeks before conventional tests or clinical symptoms signify damage.

The test may potentially improve patient care for kidney transplant patients while helping to lower sizable health care costs associated with renal transplant failure, Quest Diagnostics said in a statement.

The new test is based on the RNA genetic markers forkhead box P3 (FoxP3), granzyme B (GZMB), and perforin (PRF1) licensed exclusively from Beth Israel Deaconess Medical Center, Boston, and Weill Cornell Medical College, New York.

"Molecular diagnostics to noninvasively detect and predict renal-transplant rejection and monitor the efficacy and safety of pharmaceutical drug therapy and treatment withdrawal have the potential to significantly improve treatment and outcomes for renal transplant patients," said Terry Strom, MD, of Harvard Medical School Beth Israel Deaconess Medical Center. "The first molecular test for this purpose has opened the window to new opportunities for personalized and more effective management of renal graft patients."

Dr. Strom and Manikkam Suthanthiran, MD, of Weill Cornell Medical College, have published research demonstrating that certain biomarkers, including FoxP3, are useful in detecting acute cellular rejection of renal transplants.

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Local Realtor, business owner dies in Rochester - Brookings Register
Brookings Register
A Brookings man who became the focus of a community controversy over who could be treated at the Brookings dialysis center died Sunday at St. Mary's Hospital in Rochester, Minn. John Gustafson, a prominent local businessman, was being treated for

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Defense rests in bleaching deaths trial - KSLA-TV
LUFKIN, TX (KTRE) -

The defense has rested in the capital murder trial of former dialysis nurse Kimberly Clark Saenz.

Saenz, 38, of Pollok, is charged with capital murder and five counts of aggravated assault. She allegedly injected bleach into the bloodstream of kidney dialysis patients.

Testimony continued Monday afternoon with the defense calling upon a forensic pathologist, Amy Gruszecki, who testified that she believed the patients listed in the indictment got sick or died from natural causes.

Alleged victim Carolyn Risinger's husband, Jim, testified that his wife was not injured at the hand of Saenz.

The rebuttal phase began Tuesday morning, with the state calling upon Dr. Charles Crumb, medical director with Rosenburg Dialysis.

Crumb began by calling out what he noticed in patient charting conducted by DaVita Dialysis.

The prosecution asked the witness if it was abnormal for the blood pressure to change in a person. Crumb replied that this is typical of everyone, unless blood pressure has a large change.

"In a normal person blood pressure changes from minute to minute, unless it's a drastic change," said Crumb.

The prosecution asked the witness if he saw anything in Garlin Kelley's chart, on the day he had a heart attack, that indicated something was different. Crumb testified that the patient's blood pressure appeared normal in his charting.

"The treatment that day was the same as any other treatment," said Crumb.

The witness testified that in reviewing Thelma Metcalf's charting on April 1, there was nothing medically that was a cause of concern to him.

Saenz's attorney, Ryan Deaton pointed out that on July 7, 2011, there was a picture where it appears that the witness is allegedly arguing with the Texas Coalition for the abolishment of the death penalty.

"Do you believe in the death penalty?" asked Deaton.

"Yes," said Crumb.

Deaton then asked Crumb why he was seen pictured next to the group who appeared to be protesting.

"I was trying to get home," said the witness.

Deaton asked the witness why he was outside of his car if he was on his way home.

"I got out of my car because I couldn't get my car through," said Crumb.

"Clearly they are not blocking the street," said Deaton. "You can see in this picture that cars are passing through."

The witness said that he shared a few words with the group, but says he did not share in spreading their message.

"I did say I didn't agree with them. I wanted them to get out of the way so I could go home," said Crumb. "I was not arguing. I do not argue."

Deaton then asked the witness about the rate of which fluid is removed during dialysis treatment, called ultrafiltration. According to an article, published in the 2011 International Society of Nephrology, which he references, Deaton says ultra filtration rates of 10 to13 are high and can be unsafe for dialysis patients. He further says rates of 13 and above is too high for every patient.

"Your risk for cardiac arrest at an ultra filtration rate of 15 almost doubles, and it goes up from there," said Deaton referring to the same article on ultra filtration.

Deaton pointed out that chart records show Marva Rhone's ultra filtration rate (UFR) was 13.8, Carolyn Risinger's was 20.8, and Debra Oates' was 11.8.

When the witness revealed that he had not calculated the patients' rates, Deaton asked Crumb when he was hired as a witness by the state.

"Last Friday," said Crumb.

Deaton says that has not been long enough time for Crumb to review enough information to make sufficient arguments in the case.

"Yet, you're up here trying to tell the jury what is right or wrong at the clinic," said Deaton.

Deaton further argued that Crumb has not looked over patients' medical history on top of not calculating the ultra filtration rates.

"Is that fair?" said Deaton.

Deaton then pointed out to Crumb that from the calculations he's conducted, the DaVita patients listed in the indictment had high UFR's.

"Every single one of Dr. Nazeer's patients had ultra filtration rates over the rate of 10," said Deaton.

Deaton said that the jurors in the trial know more about medical histories, at this point, than the witness. The witness agreed this assertion was true as well as admitted that he did not review witness statements.

The witness testified that he read nephrology articles on a regular basis, although he had not read the two articles Deaton referenced while Crumb was on the stand.

In cross-examination, the witness argued that the process of ultra filtration may be a factor in patient deaths, but the amount of fluid needed to flush out a patient's body could also be a factor.

"The ultra filtration may be a factor," said Crumb.  "The patient that needs the most ultra filtration needs the most fluid."

Crumb argued that there was not extra fluid found in the patients' bodies. He also told jurors he has been in the process of dialysis for the past 40 years.

The prosecution called upon Larry Christenson, who testified he is employed with the City of Lufkin Fire Department as a paramedic. He told jurors he has worked there for 7 years.

Christenson said he was dispatched to DaVita Dialysis the day Graciela Castenada had a medical episode at the Lufkin clinic.

"She was not breathing and no pulse," said the witness.

The witness said he did not recall seeing anything obstructing Castenada's airways when she was in his care.

"Do you remember this honestly or are you just going off the record?" said Deaton.

"I'm just going off the record," said the witness.

"And do ya'll always put everything in the record?" said Deaton.

"Yes," said Christenson.

The prosecution next called upon John Rowles, a paramedic with the City of Lufkin Fire Department. He stated that he was the lead medic dispatched to DaVita Dialysis on April 16, 2008, after Castenada's episode at the clinic.

"She was critical with cardiac arrest," said the witness.

The witness testified that he had trouble originally trying to put a tube into Castenada's throat.

"She had secretions that we had to suction twice," said the witness.

Prosecuting attorney, Clyde Herrington, asked the witness if he found gum inside of Castenada's throat when he suctioned her airway. The witness replied he did not, and if he had, it would have been documented since he was the writer of the paramedic report.

"If I had seen something out of the ordinary, I would have written it in the report," said the witness.

Deaton pointed out that an evaluation conducted by a doctor when Castenada was taken to the emergency room of a hospital, chewing gum was documented in her airway. The witness says when he arrived on scene, Castenada was not breathing on her own.

"She is not breathing and does not have a pulse," said the witness.

However, when he gets her to the ER, Rowles says Castenada is breathing on her own.

The defense called upon Donna Hartsfield as the next witness, who previously testified in this trial that she worked for DaVita Dialysis.

Deaton asked her about the meetings held at DaVita, to which the witness testified Amy Clinton held the meetings. She said Clinton was generally the sole speaker at the meetings.

"There was a statement that was said regarding if I go down, I won't go by myself. There was a big stink about why that was said," said the witness.

While the witness says she does not remember who made the statement, she says Clinton is the only speaker at the meetings. However, employees made comments during the meetings, the witness recalled.

"I don't recall who actually made the statement. I remember it being said, but I don't remember who said it," said the witness.

The witness recalled the statement came up in a meeting setting in serious conversation. She remembers it was not brought up in casual talk.

The trial is now in recess until closing arguments begin Thursday morning at 9 a.m.

Copyright 2012 KTRE. All rights reserved.

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Beyond the Abstract - Second-line therapy for refractory renal-cell carcinoma ... - UroToday

Beyond the Abstract - Second-line therapy for refractory renal-cell carcinoma ...
UroToday
Worth mentioning is the opportunity to use sorafenib as first-line in selected patient populations such as the elderly or patients with comorbidities including hypertension, left ventricular ejection fraction abnormalities, and renal failure.

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Affymax Wins Approval of Drug for Anemic Kidney Patients - Bloomberg

Affymax Inc. (AFFY) won U.S. approval for Omontys, a competitor to Amgen Inc. (AMGN)’s anemia treatments that have been the only options for patients with loss of kidney function for more than 20 years.

The Food and Drug Administration cleared Omontys, known as peginesatide, for patients with chronic kidney disease on dialysis, the agency said today in a statement. The drug will be Palo Alto, California-based Affymax’s first marketed product.

“There has been and continues to be a lot of interest across the board from dialysis providers,” John Orwin, chief executive officer for Affymax, said in a telephone interview.

Approval of the drug -- intended to be used once a month instead of as often as three times a week for Amgen’s Epogen -- may save money for Medicare, the U.S. health program for the elderly and disabled. Peginesatide may generate as much as $700 million in peak sales by 2017, Ian Somaiya, an analyst at Piper Jaffray & Co. in New York, said in a telephone interview.

Affymax gained 4.2 percent to $14.31 at the close in New York. The company’s shares have gained 135 percent in the past 12 months.

“We’re dealing with a monopoly right now and that’s not ideal because it’s occurred for two decades,” Somaiya said of Epogen. “Small and medium dialysis centers are price sensitive. Peginesatide would be the choice for these dialysis providers.”

Dialysis removes toxins from the blood when kidneys can’t.

Drug Tryout

Orwin anticipates that large dialysis providers may try out Omontys in some centers before agreeing to use it in every facility. Fresenius Medical Care AG (FME), the largest dialysis provider by annual revenue, participated in final-phase clinical trials and is involved in continuing studies, making it easier to access the medicine’s performance, he said.

Amgen’s Epogen, approved in 1989, generated $2 billion in sales last year, a decrease of 19 percent from 2010, according to data compiled by Bloomberg. Peginesatide may compete to a lesser extent with Thousand Oaks, California-based Amgen’s Aranesp, which is primarily used on nondialysis kidney patients. Aranesp had $2.3 billion in sales last year.

Amgen, the world’s largest biotechnology company, has deals with DaVita Inc. (DVA) of Denver, the largest U.S. dialysis provider, and Fresenius, based in Bad Homburg, Germany. The deal with DaVita is exclusive and for seven years, while Fresenius’s agreement isn’t exclusive and is for an undisclosed amount of years.

JNJ’s Procrit Agreement

Johnson & Johnson’s Procrit, the same drug as Epogen, is used only in patients who aren’t undergoing dialysis under an agreement between the New Brunswick, New Jersey-based drugmaker and Amgen, Somaiya said.

Affymax has a profit-sharing agreement for peginesatide with Osaka, Japan-based Takeda Pharmaceutical Co. (4502)

Medicare spent $6.8 billion on dialysis and drugs for kidney failure patients in 2007, according to a March 2010 report from the U.S. Government Accountability Office, the investigative arm of Congress. Medicare, which covers almost everyone with kidney failure regardless of age, began reimbursing for such services in one bundled payment last year to save money.

The medicines are part of a class of drugs known as erythropoiesis-stimulating agents that boost production of red blood cells. The FDA recommended in June that doctors use the lowest possible doses of the agents because of potential heart risks. The agency in 2006 first warned that high doses of the anemia drugs may cause heart attacks and strokes.

Omontys will be available within four weeks, Orwin said, and the company expects to have a sales force of as many as 80 people hired within 30 days to 60 days.

The company may support another product and may look again to kidney diseases, he said.

“There remains a significant unmet need in the renal space,” Orwin said. “At some point we could consider other specialty areas when we’ve exhausted that space.”

To contact the reporter on this story: Anna Edney in Washington at This e-mail address is being protected from spambots. You need JavaScript enabled to view it

To contact the editor responsible for this story: Reg Gale at This e-mail address is being protected from spambots. You need JavaScript enabled to view it

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