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Non-Dialysis CKD-MBD Care Suboptimal - Renal and Urology News
May 26, 2015 Non-Dialysis CKD-MBD Care Suboptimal - Renal and Urology News
Therapeutic inertia was 34% at 6 months. It was defined as lack of prescriptions despite hyperphosphatemia, hypocalcemia, and/or hyperparathyroidism.

A significant proportion of non-dialysis chronic kidney disease (CKD) patients have inadequately managed mineral bone density (MBD), according to a new Italian study. Therapeutic inertia appears to be a barrier to good care of these patients, researchers concluded.

For the study, Maurizio Gallieni, MD, of the Nephrology and Dialysis Unit, Ospedale San Carlo A10 Borromeo, University of Milan, and colleagues prospectively evaluated CKD-MBD management in 727 non-dialysis, Caucasian patients over 2 visits occurring 6 months apart. All patients had 1 or more markers of MBD, including hyperphosphatemia, hypocalcemia, and/or hyperparathyroidism, and all were considered compliant with prescribed therapy.

According to results published online ahead of print in the Journal of Nephrology, more than 65% of the patients did not reach parathyroid hormone (PTH) targets, 19% missed calcium targets, and 15% missed phosphate targets. Each of the 19 nephrology clinics involved in the study had their own clinical targets, although most generally followed Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations.

The prevalence of therapeutic inertia was 34% at 6 months. It was defined as lack of phosphate binder prescriptions despite hyperphosphatemia; lack of calcium and vitamin D supplements despite hypocalcemia; or lack of phosphate binders and calcium and vitamin D supplements despite hyperparathyroidism.

Therapeutic inertia was highest for hyperphosphatemia at 54%. For example, 51% of the 212 patients with serum phosphate greater than 4.1 mg/dL received neither phosphate binders nor a prescription for a low-protein diet. PTH was off-target in two-thirds of patients.

“This significant difference between PTH and phosphate-calcium control in the follow-up of our cohort is likely the consequences of early onset of PTH elevation in the course of CKD,” the researchers wrote.

The likelihood of inadequate treatment overall decreased as CKD worsened to stages 4 and 5 (by 40% and 68%, respectively).

The management of CKD-MBD in non-dialysis patients appears subpar, especially compared with the care of dialysis patients. The impetus for CKD-MBD prescriptions appeared to be worsening renal function rather than test results assessing each mineral. 

Source

  1. Gallieni, M, et al. Journal of Nephrology; doi: 10.1007/s40620-015-0202-4.

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Northwest Renal Network joins the HealthInsight ESRD Alliance - NephrologyNews.com

Northwest Renal Network, which holds the contract for ESRD Network 16, said it plans to affiliate with the HealthInsight ESRD Alliance.  The newly formed alliance also includes the Intermountain ESRD Network, which oversees ESRD Networks 15 and 17.

Northwest Renal Network and Intermountain ESRD Network will retain their corporate identity and will continue to use their current name alongside the HealthInsight ESRD Alliance name.

All 18 current ESRD Networks are now affiliated with or partnering with a QualityInnovation Network - Quality Improvement Organization (QIN-QIO). All but one of those partnerships/affiliations are multi-network in scope. By working together, the partners will be more efficient and effective in how they execute the ESRD and QIN-QIO activities, and ensure a broader impact in their communities. This collaboration will work toward transforming health care to achieve improved quality, safety and value for ESRD patients and to assure continuity of exceptional care. 

“We believe that there will be immediate synergy as we bring the strength and long history of outstanding quality outcomes of Northwest Renal Network with Intermountain ESRD Network and HealthInsight” said Marc Bennett, HealthInsight president and CEO. “Adding Northwest Renal Network to our partnership will further enrich our ability to create opportunities for meaningful innovation and for a significantly broader geographic implementation of quality initiatives.”

Northwest Renal Network holds the CMS contract for ESRD Network 16 and has served as an ESRD Network organization since 1978. Network 16 serves Alaska, Idaho, Montana, Oregon and Washington.

“Northwest Renal Network is excited to be joining HealthInsight and Intermountain ESRD Network as part of the HealthInsight ESRD Alliance,” said Katrina Russell, RN, CNN, board chair of Northwest Renal Network. “We believe this partnership will help us enhance our ability to bring quality care to the patients we serve and will expand the capabilities of all partners combining resources and expertise for the benefit of those who suffer with kidney disease.”

                                                        

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Phosphorus Control Linked to Self-Motivation in ESRD - Renal and Urology News
May 26, 2015 Phosphorus Control Linked to Self-Motivation in ESRD - Renal and Urology News
Implementing culturally relevant interventions that improve patient self-motivation is a strategy that could increase medication adherence, the researchers suggest.

Self-motivated, non-Caucasian dialysis patients are more likely to take their phosphate binder medication and, in turn, enjoy better phosphorus control, according to a recent study.

Implementing culturally relevant interventions that improve patient self-motivation is a strategy that could increase medication adherence, the researchers suggest. Treatment non-adherence in the end-stage renal disease (ESRD) population tends to be high, ranging from 22%–74%.

To assess patient motivation to comply with phosphate binder therapy, investigators led by Kerri Cavanaugh, MD, of Vanderbilt University Medical Center in Nashville, asked 100 ESRD patients (most on dialysis) to take an adapted version of the autonomous regulation (AR) scale. The AR scale allows responses ranging from 1 (not at all true) to 7 (very true). A separate tool, the Morisky Medication Adherence Scale, gauged actual medication usage based on patient reports. The average serum phosphorus level was 5.7 mg/dL.

More than half of patients reported the highest AR score of 7, according to results published online ahead of print by the Journal of Renal Nutrition. Higher AR scores were associated with better medication adherence, and better medication adherence was linked to lower serum phosphorus.

The researchers noticed that results differed by race. Higher AR scores in non-Caucasian patients correlated with lower serum phosphorus. This was not true of Caucasian patients. The most motivated patients were non-Caucasian, older women with average age 53.

Ethnic minority patients were significantly more likely to report the highest AR scores for 3 questions identifying reasons for taking phosphate binders: the medication is important for being as healthy as possible, it is the best thing for my health, and it is important for many aspects of my life.

“Non-white dialysis subjects have an increased prevalence and severity of bone mineral disorder, and perhaps over time, this experience with more severe disease may result in higher AR toward phosphate binders as an adaptive mechanism compared to their white peers,” the investigators explained.

The type of phosphate binder had no bearing on the results. The most commonly taken phosphate binders were sevelamer carbonate (40%) and calcium acetate (33%), although all types were reported.

Source
  1. Umeukeje, EM, et al. Journal of Renal Nutrition; doi: 10.1053/j.jrn.2015.03-001.

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Older patients are saying no to dialysis - Sarasota Herald-Tribune

Gerald J. Hladik was 74 when the day anticipated by his doctors arrived: His kidneys, damaged years earlier by a viral infection, had lost 85 percent of their function.

Time to begin dialysis.

Older patients are saying no to dialysis - Sarasota Herald-Tribune

Some older adults with advanced kidney failure are resisting the usual answer by deciding the sacrifices required by the treatment aren't worth it. (Carl Wiens/The New York Times)

But from the beginning, Hladik resisted. An IBM retiree, he loved fishing, boating and gardening — and hated hospitals.

“He wanted to be at home with his dog. He wanted to be able to go to the beach,” recalled his son, Dr. Gerald A. Hladik.

A nephrologist at the University of North Carolina School of Medicine, Gerald A. Hladik understood better than most how kidney dialysis could consume a patient’s days. His father’s eventful medical history included a serious stroke and coronary bypass surgery.

“Dialysis may have prolonged his life, but I suspect only by a couple of months,” Hladik said.

So after considerable discussion, the elder Hladik decided to skip the three weekly trips to a renal center. His doctors managed his heart disease and hypertension with drugs. He died at home in November, a year and a half after saying no to dialysis.

People over age 75 are the fastest-growing segment of patients on dialysis, and the treatment’s benefits and drawbacks add up differently for them than for younger patients. A growing number of nephrologists and researchers are pushing for more educated and deliberative decision-making when seniors contemplate dialysis.

It is a choice, they say, not an imperative.

“Patients are not adequately informed about the burdens. All they’re told is, ‘You have to go on dialysis or you’ll die,’ ” said Dr. Alvin H. Moss, a nephrologist at West Virginia University School of Medicine and chairman of the Coalition for Supportive Care of Kidney Patients. “Nobody tells them, ‘You could have up to two years without the treatment, without the discomfort, with greater independence.’ ” Dialysis involves filtering impurities from the blood when a patient’s kidneys can no longer do so.

Unquestionably, dialysis has helped save lives. The mortality rate for patients with chronic kidney disease decreased 42 percent from 1995 to 2012, according to the most recent report from the U.S. Renal Data System.

The picture for older patients is less rosy. About 40 percent of patients over age 75 with end-stage renal disease, or advanced kidney failure, die within a year, and only 19 percent survive beyond four years, the renal data system has reported. A primary reason is that older patients like Hladik generally suffer from other chronic conditions.

“Dialysis only treats the kidney disease,” said Dr. Ann O’Hare, a nephrologist at the University of Washington School of Medicine. “It doesn’t treat the other problems an older person may have. It may even make them more challenging to deal with.”

Typical hemodialysis sessions take place three times a week, and each lasts three to four hours — a regimen O’Hare compares to holding down a part-time job. Afterward, “patients may have cramping. They can feel dizzy, washed out,” Moss said. Many report pain or nausea.

“A typical older dialysis patient will say, ‘I just go home afterwards and go to bed,’ ” Moss said. After the good day that usually follows, the cycle repeats.

More conservative approaches to kidney disease do exist and can improve older patients’ quality of life. Medication to control blood pressure, treat anemia, and reduce swelling and pain, “these are treatments that will keep people comfortable for long periods,” Moss said. “People choosing medical management could live 12 to 18 months, 23 months.”

And spend less of that time in medical facilities.

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Argos' Cell Immunotherapy Phase 3 Trial for Advanced Renal Cancer is ... - Immuno-Oncology News

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Argos Therapeutics Inc., a company focused on personalized immunotherapies for cancer treatment, recently announced that the ongoing pivotal phase 3 ADAPT clinical trial (NCT01582672) of its product AGS-003 for the treatment of metastatic renal cell carcinoma has enrolled approximately 400 patients and collected more than 1,000 cancer samples.

Argos’ AGS-003 is a product based on the company’s Arcelis Technology Platform, which is a fully personalized immunotherapy technology designed to overcome immunosuppression by inducing a durable memory T cell response specific for each patient’s cancer. AGS-003 is produced using a small sample from the patient’s tumor and own dendritic cells (scavengers that recognize cancer cells and present them to T cells in order to mount an immune response). These are collected and optimized following a single leukapheresis procedure, a process in which white blood cells are separated from a blood sample. RNA is isolated from the patient’s tumor sample in order to program dendritic cells to target specific cancer antigens. These activated dendritic cells are then administered back into the patient.

“We have observed a significant level of interest in this trial evaluating AGS-003, a fully customized and well-tolerated immunotherapy, in combination with standard surgery and targeted therapy for patients who present with newly diagnosed, metastatic kidney cancer,” said ADAPT trial principal investigator Dr. Robert Figlin in the press release. “With the strong multidisciplinary collaboration between urologists and oncologists across our study base, we are excited to be completing enrollment to this important trial in the coming weeks.”

The ADAPT trial is expected to enroll around 450 patients who are good candidates for standard surgery and targeted drug therapy. Argos plans to conclude the ADAPT trial enrollment phase by the end of June 2015.

Dr. Figlin will present data on the ADAPT trial at the upcoming 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, on June 1st in a poster entitled “Patient identification and eligibility insights in the synchronous metastatic RCC population: An update from the ongoing ADAPT phase 3 study experience”.

“We continue to be pleased and highly encouraged by the tremendous interest in the largest global trial ever performed in the newly diagnosed, unfavorable risk mRCC [renal cell carcinoma] patient population,” said the President and CEO of Argos, Jeff Abbey. “Even with surgery and approved targeted therapies, these mRCC patients are only expected to survive an average of 15 months after diagnosis. We look forward to the readout from this trial by the second half of 2016, when we hope to confirm the encouraging survival results we observed in our phase 2 trial involving AGS-003 combined with sunitinib [an anti-cancer drug].”

Metastatic renal cell carcinoma patients have an extremely poor five-year survival rate and, different from other types of cancer, patients usually have a poor response to chemotherapy and radiation therapy. New effective therapies are therefore urgently needed.

If you are interested in participating in this Phase 3 clinical trial, please contact the Adapt Study Team via This e-mail address is being protected from spambots. You need JavaScript enabled to view it or 1-877-573-9235.

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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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