PKD & Kidney Treatment
From NephrologyNews.com
UPDATE: An earlier version of this article stated in the headline that hemodialysis patients treated in for-profit centers have higher mortality rates. The study actually only shows higher rates of hospitalization, not mortality.
Patients receiving hemodialysis in for-profit facilities had a 15% higher relative rate of hospitalization compared with those in nonprofit facilities, a study published online Dec. 26 in the Clinical Journal of the American Society of Nephrology found.
Researchers conducted a retrospective cohort study using the U.S. Renal Data System, including all adults aged 18–100 years old who started dialysis between Jan. 1, 2005 and June 30, 2008. Patients who died, received a kidney transplant, recovered kidney function, or were lost to follow-up in the first 90 days of dialysis were excluded. The cohort included 150,642 dialysis patients, of which 12,985 (9%) were receiving care in nonprofit dialysis facilities. In adjusted models, the study authors said they found patients receiving hemodialysis in for-profit facilities had a 15% higher relative rate of hospitalization compared with those in nonprofit dialysis facilities. Patients on hemodialysis receiving care in for-profit dialysis facilities had a 37% higher rate of hospitalization for heart failure or volume overload and a 15% higher rate of hospitalization for vascular access complications. Among patients receiving peritoneal dialysis, the rate of hospitalization in for-profit versus nonprofit facilities was not significantly different, according to the study.
(CMS takes a step back on tackling hospitalizations under the ESRD QIP)
"Proposed mechanisms by which profit status and organizational structure may be linked to adverse outcomes include differences in staffing, training level of staff, and specific differences in treatment or processes of care such as hemodialysis session length and medication dosing protocols," the authors wrote.
Baseline characteristics for adults on hemodialysis differed among those in for-profit compared with nonprofit dialysis facilities. The proportion of patients with hemodialysis catheters at the start of dialysis was higher in for-profit facilities. The prevalence of atherosclerotic heart disease, cerebrovascular accident or transient ischemic attack, cancer, pulmonary disease, and inability to ambulate or transfer was significantly higher in nonprofit facilities, the authors wrote. The proportion of patients with reported nephrology care before ESRD was higher in nonprofit facilities, and the distribution of patients by profit status differed by region. In adults on peritoneal dialysis, the prevalence of baseline chronic diseases was similar among patients in for-profit and nonprofit dialysis facilities.
"Amid the concerns about whether ESRD patient outcomes are affected by the profit status of dialysis providers, it is important to stress that not all for-profit providers are equal, and even if there is some relationship between outcomes and profit status, that characterization may not apply to all for-profit (or nonprofit, for that matter) organizations," Barry M. Straube, MD, said in an accompanying editorial. [Read more}
From PharmaBiz.com, News Release
The European Medicines Agency (EMA) has accepted marketing authorisation application (MAA) for the potential approval of Otsuka Pharmaceuticals' tolvaptan for treatment of autosomal dominant polycystic kidney disease (ADPKD). Phase III clinical trial results that form the basis of the regulatory filing were published in the New England Journal of Medicine.
“Otsuka is delighted that the EMA will review the tolvaptan MAA for the treatment of ADPKD, based on compelling data from our pivotal three-year Phase III clinical trial,” said Ole Vahlgren, CEO & president, Otsuka Europe. “If approved, tolvaptan will represent a breakthrough for patients with a disease for which there are currently no licensed treatments.”
Tolvaptan is a selective V2 vasopressin receptor antagonist that has been hypothesised to slow the progression of ADPKD by reducing the development and growth of kidney cysts.
ADPKD is a hereditary genetic disease characterised by the development of multiple, non-malignant cysts in the kidneys due to inherited or acquired genetic mutation(s). Cyst growth and expansion in both kidneys leads to slow deterioration of kidney function, and in approximately 50 per cent of patients, to end-stage renal disease (ESRD) and renal failure. ADPKD typically results in symptom manifestations (e.g. hypertension and kidney pain) in adulthood. Half of all ADPKD patients will require dialysis or transplantation by the age of 60 and people with ADPKD account for up to one in 10 people on maintenance dialysis. The condition is estimated to affect approximately 200,000 people in Europe.
The Committee for Medicinal Products for Human Use (CHMP), a committee within the EMA, is responsible for evaluating the application and will provide a recommendation on whether tolvaptan should receive marketing authorisation. The CHMP may request further information from the applicant before adopting an opinion. If the committee’s opinion is positive, it is forwarded to the European Commission to make the final decision.
In August 2013, the EMA’s Committee for Orphan Medicinal Products (COMP) granted tolvaptan orphan drug designation for the treatment of ADPKD. To qualify for orphan designation, the prevalence of the condition in the EU must not be more than five in 10,000. In addition, the new medicine must be of significant additional benefit to those affected by the condition, and no satisfactory method of diagnosis, prevention or treatment of the condition must exist.
In Japan, the application for ADPKD is currently under review. In the United States, Otsuka and FDA have been working together to determine the most appropriate path forward to allow tolvaptan to be available for patients suffering from ADPKD.
From YottaFire.com, Press Release
Testing technique could lengthen lifespan of dialysis patients
New approach spots deadly hormone imbalances in end-stage kidney disease patients
A new testing method can better detect potentially fatal hormone imbalances in patients with end-stage kidney disease, according to a recent study accepted for publication in The Endocrine Society’s Journal of Clinical Endocrinology & Metabolism (JCEM).
At the end of 2009, more than 871,000 Americans were being treated for end-stage renal disease, according to the National Institutes of Health’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). These patients require dialysis or kidney transplants to stay alive. About 10 to 20 percent of patients with chronic kidney disease stage 5, or end-stage renal disease, die each year.
One key factor that contributes to the risk of death in this population is levels of parathyroid hormone, the hormone that makes calcium available in the blood for important body functions. When parathyroid hormone levels are too low or too high, it raises the mortality risk for patients with end-stage renal disease.
“The current tests for parathyroid hormone levels overlook a key factor,” said the study’s lead author, Berthod Hocher, MD, PhD, of the University of Potsdam in Potsdam-Rehbrücke, Germany. “When parathyroid hormone interacts with oxygen under conditions of stress such as end-stage kidney disease, it becomes biologically inactive. Our new approach is the first to differentiate between non-oxidized, biologically active parathyroid hormone and oxidized parathyroid hormone. This will result in better monitoring and treatment for patients who have end-stage renal disease.”
Researchers conducted a prospective cohort study to test this approach. The study authors monitored a group of 340 dialysis patients over the course of a five-year period. Researchers tested blood samples from the patients to determine their parathyroid hormone levels. During the course of the follow-up period, 170 participants died, many from cardiovascular disease, infections or cancer.
The patients who survived had higher median levels of non-oxidized parathyroid hormone than the study participants who died. The study found an increased rate of survival among dialysis patients who had the highest levels of non-oxidized parathyroid hormone.
“With more precise parathyroid hormone testing, health care professionals will have the information they need to improve clinical outcomes,” Hocher said. “The nephrology community has long recognized there is an issue with current testing approaches, and now we can solve this problem and improve patient care.” [Read more]
From CourierMail, Brisbane, Australia, by JANELLE MILES
TEENAGER Bianca Scott faces a lifetime of kidney dialysis unless she can access a drug that costs the price of a house for only a year's treatment.
The Gold Coast 17-year-old was happy and healthy as she celebrated the end of her schooling a month ago, but within a week was fighting for her life in hospital with a rare kidney disease.
"It's been a nightmare," her mother Tammy Hamawi said. "We understand now, from our own point of view, how people's lives can change in an instant."
Her only child was first diagnosed with atypical haemolytic uraemic syndrome as a seven-month-old in New Zealand but recovered and has been relatively healthy since - until recent weeks.
The disease results in damage to the small blood vessels in the kidney and other organs, including the heart and brain, caused by a genetic abnormality affecting immune system proteins.
Bianca, whose uncle died from the condition at six years of age, is receiving a treatment, known as plasma exchange which removes and replaces the defective proteins, but the therapy has been ineffective in halting damage to her kidneys and she requires regular dialysis at the Gold Coast University Hospital.
She's been unable to access a drug, marketed as Soliris, which kidney specialist Nicole Isbel says has been effective in allowing similar patients to come off dialysis. [Read more]
From Azom.com
Clay Minerals from Ancient Volcanic Ash May Help Treat Chronic Kidney Disease
Clay has healing powers. This natural product is destined to help treat chronic kidney disease: a well-tolerated agent based on clay minerals lowers patients’ excessive phosphate levels.
Miss M. spends around 15 hours a week in hospital. Her renal functions are limited, and her kidneys are no longer able to filter toxins from her blood. She is a dialysis patient, forced to rely on this artificial blood purification treatment that, although essential, greatly impairs her quality of life. She has to make three trips a week to the dialysis clinic and going away for longer than a few days is almost out of the question. And Miss M. is no exception: In Germany alone, over six million people suffer from some form of chronic renal disease. Around 70,000 depend on dialysis and they are joined by some 15,000 new dialysis patients every year. Poor diet and an aging population are contributing to the dramatic rise in chronic renal disease worldwide, with high blood pressure and diabetes the most significant risk factors related to renal failure.
When suffering from renal failure, the body is unable to filter out phosphates in sufficient quantities, and the resulting excess is then absorbed into the blood. This causes a build-up of calcium-phosphate deposits in the blood vessels, which can over an extended period lead to arteriosclerotic heart disease and premature death. Compared to people with healthy kidneys, those with compromised renal function are at least ten times more likely to suffer a heart attack or stroke. To counteract this increased risk, people suffering from chronic renal insufficiency are required to take phosphate binders with meals. In the stomach and intestines, these medications bind to phosphates from food so that they can be excreted undigested instead of being absorbed into the blood. The problem is that existing medications, such as calcium and aluminum salts, cause serious side-effects including constipation, hypercalcemia (an elevated level of calcium in the blood), and neurologic disorders.
Gentle alternatives to pharmaceutical treatments
But hope is in sight for sufferers of chronic renal disease. Scientists from the Fraunhofer Institute for Cell Therapy and Immunology IZI in Rostock teamed up with FIM Biotech GmbH to develop an effective therapeutic agent that patients can tolerate well. Formed by marine deposits of volcanic ash 60 billion years ago, clay minerals found in the Friedland area of north-east Germany provide the basis for the new agent. The clay first has to be processed before being refined using a special technical process. [Read more]
PKD Fundraising
From PKD Foundation of Canada
December 2013 PKD e-News (Last chance to support our year-end campaign)
Support
There’s Still Two Days Left to Support Our Year-End Campaign
As 2013 draws to an end and we gather with those close to us to celebrate the holiday season, we here at the PKDFOC would like to express our heartfelt thanks to all of you, our donors, who have made 2013 our strongest year to date!
This year, we once again saw incredible growth in PKD awareness on a local and national level through our Chapter initiatives and volunteer-driven events in the community. Additionally, the Walk for PKD – our signature fundraising campaign – reached record-setting levels; bringing out 850+ people to walk for a cure, and raising more than $173,000!
With your help, we continued our support of the University Health Network’s Hereditary Kidney Disease Clinic by awarding a One-Year Translational Research Fellowship to Dr. Moumita Barua (Toronto General Hospital.) The funding of this Fellowship and the work done within this clinic couples clinical care with research, so that new knowledge for the benefit of PKD patients across Canada can be generated.
Our accomplishments over 2013 are inspiring and would not have been possible without your help. Looking ahead to 2014, we are excited to further fund leading Canadian research into a treatment and cure for PKD, but the amount of research we are able to support depends on the funds that are available.
Please make your tax-deductible gift today. Join us in the fight to END PKD.
PKD Knowledge
From MayoClinic.org, By Mayo Clinic Staff
Polycystic kidney disease (PKD) is a disorder in which clusters of cysts develop primarily within your kidneys. Cysts are noncancerous round sacs containing water-like fluid.
Polycystic kidney disease isn't limited to your kidneys, although the kidneys usually are the most severely affected organs. The disease can cause cysts to develop in your liver and elsewhere in your body.
A common complication of polycystic kidney disease is high blood pressure. Kidney failure is another common problem for people with polycystic kidney disease.
Polycystic kidney disease varies greatly in its severity, and some complications are preventable. Lifestyle changes and medical treatments may help reduce damage to your kidneys from complications, such as high blood pressure.
Kidney News
Mortality rates in end-stage renal disease (ESRD) and dialysis populations are declining but remain much higher than in the general population, according to the 2013 Annual Data Report from the U.S. Renal Data System (USRDS).
The adjusted mortality rate among ESRD patients (per 1,000 patient years at risk) decreased from 351 in 1996 to 241 in 2011, a decline of 31.3%. During that same period, the adjusted mortality rate in the dialysis population dropped from 362 to 266, a decrease of 26.5%.
In 2011, among individuals aged 65 years or older, the adjusted mortality rate was 272.5 and 314.3 per 1,000 patient years at risk in the ESRD and dialysis populations, respectively, compared with 48 in the general population.
The adjusted first-year all-cause mortality rate from day 1 in 2010 was 254.4 per 1,000 patient years at risk, 268.8 for hemodialysis (HD) patients, 121.4 for peritoneal dialysis (PD) patients, and 54.4 for kidney transplant patients (from the date of transplant). From day 90, the rate was 221.5 for HD patients and 126 for PD patients. [Read more]
Genetic factors in African Americans with chronic kidney disease (CKD) put them at a greater risk for end-stage renal disease (ESRD) compared to white Americans, according to a new study released in the New England Journal of Medicine. Researchers at Johns Hopkins University and the University of Maryland contributed data from two separate studies: the African American Study of Kidney Disease and Hypertension (AASK) and the Chronic Renal Insufficiency Cohort Study (CRIC).
Both studies identified high risk genetic variants in the APOL1 gene that speed up kidney disease progression and substantially increase the risk of developing kidney failure, compared to whites and blacks with low risk variants, with or without diabetes. Approximately 1 in 10 blacks possess the high risk variants, though it is very uncommon in whites.
“Even though our studies found that African Americans with two copies of the high-risk APOL1 variants were at higher risk for kidney disease progression, about 40% of the African Americans from the AASK study who also carried the high-risk variants had not progressed at the time of the study,” said co-lead author W.H. Linda Kao, PhD, MHS, professor of epidemiology and medicine at Johns Hopkins University. “This finding highlights the importance of identifying factors that may modify the effect of the APOL1 risk variants.”
Senior author Lawrence J. Appel, MD, MPH, professor of medicine, epidemiology, and international health at the Johns Hopkins Medical Institutions, noted the importance of the APOL1 gene and its effect on kidney disease progression in blacks.
“Blacks with chronic kidney disease and the high-risk genetic variants were more likely to have kidney disease that progressed, compared to both blacks without the high-risk genotype and whites,” he said.
Appel also stated that African Americans with low-risk variants still had a higher risk of developing kidney failure than whites.
“What we found is pretty remarkable — that variations in a single gene account for much of the racial disparity in kidney disease progression and risk for end-stage kidney disease,” says co-lead author Afshin Parsa, MD, MPH, assistant professor of medicine at the University of Maryland School of Medicine. “If it were possible to reduce the effect of this gene, there could be a very meaningful decrease in progressive kidney and end-stage kidney disease within blacks.” [Read more]
In a wealthy country like Australia, kidney disease is born out of poverty and dispossession, but the Aboriginal communities in Central Australia hit the hardest are tackling it with a blend of traditional and modern medicine.
In the 1990s, Pintupi communities such as Kintore in the Northern Territory and Kiwirrkurra in Western Australia watched helplessly as many of their senior people had to move up to 700km into town for dialysis, dislocating families and disrupting cultural flow.
"People's kidneys would be failing, they'd know that dialysis was a one-way ticket to Alice Springs and they'd only heard bad stories," says Sarah Brown, manager of Western Desert Dialysis.
"So they'd hide out for as long as possible, get really crook and be evacuated into town, and then it would be a crisis and outcomes would be really bad."
After failing to secure government funding for remote dialysis machines so people could be treated at home, the communities painted big collaborative artworks in 2000 and with the help of Papunya Tula Artists' Centre and Sotheby's auction house auctioned them off at the Art Gallery of NSW.
They raised $1.1 million of independent money "to do something to improve the lives of their mob whose kidneys were buggered", Ms Brown tells AAP.
Western Desert now runs the Purple House in Alice Springs, which has two dialysis machines, and the Purple Truck, which travels Central Australia to bring mobile dialysis to people living in more than 20 remote communities.
There are two machines each now in Kintore, Yuendumu, Hermannsburg, Lajamanu and Warburton, making a total of 14 for the region, and they can treat about 40 patients a day.
This reach is crucial, because Central Australia has the highest per capita rates of kidney disease in the world.
In Australia, it's 15 to 30 times the national average, the result of a combination of factors that stem predominantly from poverty. [Read more]
From NWITimes.com, NorthWest Indiana, by Jim Myers, Guest Commentator
According to the National Kidney Foundation, 26 million American adults are estimated to have chronic kidney disease, yet many do not know it. Early signs are hard to detect and are easily missed.
Nearly 2.5 million Medicare patients are estimated to have CKD that has not yet become kidney failure. Nearly 600,000 Americans have irreversible kidney disease or end-stage renal disease, which requires dialysis or a transplant to survive.
Nearly 99,000 Americans are on the kidney transplant waiting list. Forty-four percent of ESRD patients had a primary diagnosis of diabetes, the leading cause of ESRD. Twenty-four percent of ESRD patients had a primary diagnosis of hypertension (high blood pressure), the second leading cause of ESRD.
Nearly 3,000 people are added to the kidney waiting list every month. Thirteen people die each day while waiting for a life-saving transplant.
Kidney disease is expensive. The annual cost of the Medicare ESRD program is $28.4 billion. The annual Medicare costs to treat people with CKD is $41 billion, or 22.5 percent of Medicare spending.
Undetected chronic kidney disease can lead to costly and debilitating irreversible kidney failure. However, cost-effective interventions are available if patients are identified in the early stages.
The National Kidney Foundation's Early Evaluation Program reached more than 185,000 individuals at increased risk for developing kidney disease between August 2000 and June 2013. KEEP screenings were offered across the United States to individuals 18 years and older with high blood pressure, diabetes or a family history of kidney failure.
The National Kidney Foundation is calling on health care professionals to screen patients in specific high-risk groups for kidney disease — those age 60 or older and those with high blood pressure or diabetes — by adding a simple urine albumin test for kidney damage to annual physical examinations.
Early detection of kidney disease is critical to stopping the progression of the disease. If you are diagnosed early enough, your kidney disease can be controlled, slowed or delayed with the help of your doctor.
The risks of kidney disease and its complication can be reduced by controlling your blood pressure, maintaining proper weight, quitting smoking, exercising and avoiding excessive pain medication.
I am living proof of this. I lost a cousin, two aunts and an uncle to kidney disease. I lost my dad to polycystic kidney disease. I was diagnosed a mere two months after my father’s death at the age of 25. {Read more]
Sheba Medical Center director Rotstein: Ex-PM was not on dialysis, but doctors administered antibiotics due to numerous infections.
Former Prime Minister Ariel Sharon is in critical condition, and his life remains in danger due to a deterioration in the function of vital organs, the head of Sheba Medical Center at Tel Hashomer said on Thursday.
Professor Ze'ev Rotstein told reporters on Thursday that Sharon, who was reported to have been suffering from serious kidney failure, was not on dialysis, but that doctors were administering antibiotics due to numerous infections.
"He's getting all the treatment necessary," Rotstein said.
Sharon’s life has been hanging in the balance over the past two days due to what Rotstein said was "a serious deterioration in his health."
Sharon's long-time spokesman, Ra'anan Gissin, said that the former prime minister's kidneys have deteriorated, and "there is no doubt that it is terminal. We can't see any recovery or improvement in his health condition." [Read more]
Kandara Kidney Center (KKC), a subsidiary of the Jeddah Charity Society, conducted 7,925 dialysis operations for 58 patients this year.
Waleed Bahamdan, secretly general of Al-Birr Charity, said the organization provides kidney dialysis operations to underprivileged patients in line with international medical standards.
He pointed out that 62 percent of the patients the organization received are male, while 38 percent are women.
The organization provides other services including awareness programs against the disease, emergency treatment, periodic monitoring of patients’ health condition, and monthly medication.
Bahamdan explained that the society organizes awareness programs as well as dietary consultations for patients to educate them about the healthy lifestyle guidelines to follow.
The official pointed out that they receive donations from various establishments to provide high quality medical care for underprivileged individuals suffering from renal failure.
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