Stories from the dialysis comunity across the globe.
Study: Generic transplant drugs as good as brand name - NephrologyNews.com
A University of Cincinnati (UC)-led research team has found that generic formulations of tacrolimus, a drug used post-transplant to lower the risk of organ rejection, are just as good as the name-brand version.
The findings were presented Sunday, May 3, by lead investigator Rita Alloway, PharmD, UC research professor of medicine and director of transplant clinical research within the UC Department of Internal Medicine, and her study collaborators at the 2015 American Transplant Congress annual meeting in Philadelphia.
Funded by the U.S. Food and Drug Administration, the study was a prospective, blinded, six-way crossover study in kidney and liver transplant patients. It tested whether the two most disparate generics, based on potency, purity and dissolution ("Generic Hi" and "Generic Lo"), are bioequivalent to the drug tacrolimus (Prograf) in stable transplant patients.
The researchers analyzed a total of 70 patients who were transplanted at either University of Cincinnati Medical Center or The Christ Hospital transplant programs. Patients were given brand name tacrolimus or one of two generic versions.
"We found there to be essentially no difference in the formulations between the generics and brand-name version," says Alloway. "In other words, if you were on brand and switched to generic—and you take your medication as instructed—there should be no clinical consequence."
Alloway stresses, however, that despite their team's findings, patients are still encouraged to report any product concerns to the FDA.
The findings are important, says Alloway, because while more than 70% of tacrolimus dispensed is generic--with no consistent negative reports--physicians and patients still have concern over the use of generics post-transplant.
"Most immunosuppressant drugs require individualized dosing and careful management to ensure the proper blood concentrations are maintained," says Alloway. "Too high exposure to these drugs increases the risk of toxicity, over-immunosuppression and cancer in patents. Too low exposure may lead to rejection of the organ by the patient's immune system."
Alloway says it's these strict conditions that cause concern that the quality, pharmacokinetics and therapeutic efficacy of new drugs may differ from the branded, or innovator, product.
To analyze drug levels and pharmacokinetics as well as pharmacogenetics, Alloway collaborated with Uwe Christians, MD, PhD, professor of anesthesiology at the University of Colorado, and Sander Vinks, PharmD, PhD, UC professor of pediatrics and director of the Division of Clinical Pharmacology at Cincinnati Children's Hospital Medical Center.
"Drs. Christians and Vinks provided expertise in tacrolimus level analysis and pharmacokinetic-pharmacogenetic data analysis," says Alloway. "The study design incorporated the most sensitive and specific tacrolimus level analysis while evaluating different methods of bioequivalence data analysis."
Alloway and team will continue this important research through an FDA-funded study of patients who are at risk of experiencing lower concentrations and subsequent rejection episodes because they have been shown to require larger doses of tacrolimus to attain therapeutic blood concentrations.
Those data, Alloway says, "will allow us to characterize unique factors which may affect tacrolimus levels to identify if formulation has an effect in this enriched population."
Disclosures Prograf (tacrolimus) is manufactured by Astellas Pharma Inc. Alloway has received clinical research support from and has served on the advisory board to Astellas.
She also reports receiving clinical research grants from Novartis, Veloxis, Takeda, Onyx, GSK, Prolong, Bristol-Myers Squibb, Chiltern and Sanofi. She has served on the advisory boards of Veloxis, Sanofi and Amgen.
DENVER, May 4, 2015 /PRNewswire/ -- DaVita Kidney Care, a division of DaVita HealthCare Partners Inc. (NYSE: DVA) and a leading provider of kidney care services, recognizes the month of May as Mental Health Month. It brings light to the struggles of people living with invisible illnesses like depression and the difficulties in overcoming those adversities.
"People with kidney disease and their caregivers may find themselves facing depression as they adjust to life on dialysis," said Duane Dunn, director of social work services at DaVita Kidney Care. "In the words of one of our patients, 'dialysis isn't an easy thing to go through, but end-stage renal disease isn't end stage – it's just another stage in your life.'"
Discovering a sense of purpose can be fundamental to a high quality of life on dialysis, especially as people first adjust to life on dialysis and re-enter their communities with new challenges. Whether that purpose derives from working, volunteering, parenting, attending school or other hobbies and interests, the important part is to find the motivation to thrive on dialysis.
For both patients and their caregivers, resource access is a critical component in managing mental health. Here are some tips for thriving while on dialysis:
Openly discuss –Talk with your nephrologist and social worker because they understand where patients struggle most in adjusting and coping to life on dialysis.
Seek counseling –Outpatient services are available in a variety of different agencies and can be accessed by the local Department of Human Services.
Find a support group –Look for support groups that can understand and empathize with what's happening. There are local in-person support groups as well as online options that can help provide guidance.
Seek Kidney Disease Education –Attending a kidney disease education class allows attendees to ask questions about kidney disease and get an understanding of life on dialysis.
Continue to work –Dialysis patients who continue to work are 21 percent less likely to experience symptoms of depression, according to a study published in the Clinical Journal of the American Society of Nephrology. Working may provide a sense of purpose and a positive distraction from dialysis, all of which help contribute to a better quality of life.
DaVita Kidney Care recently launched its Empowering Patients Program, designed to enhance social workers' skill sets to further help improve patients' quality of life through behavioral activation, mindfulness and coping skills. A poster on this program was presented during the National Kidney Foundation Spring Clinical Meeting in April 2015 and was recognized as a "Healthcare Professional Top Poster." The poster highlighted symptom-targeted interventions (STI) by social workers to help decrease patients' missed dialysis treatments. Aspects of the program included deep breathing, coping thoughts and behavior activation. Results suggest that a social-worker-based STI program improved quality of life for patients involved.
DaVita Kidney Care has shown itself to be a leader in putting quality at the forefront of the conversation. This has been recognized by the Center for Medicare and Medicaid Services (CMS) with the Five-Star Rating System and CMS' Quality Incentive Program (QIP). DaVita Kidney Care was recognized with 50 percent of its centers receiving a four- or five-star rating. With QIP, 98.5 percent of DaVita Kidney Care's centers rated among the top clinical performance tiers in the country.
About DaVita Kidney Care
DaVita Kidney Care is a division of DaVita HealthCare Partners Inc., a Fortune 500(r) company that, through its operating divisions, provides a variety of health care services to patient populations throughout the United States and abroad. A leading provider of dialysis services in the United States, DaVita Kidney Care treats patients with chronic kidney failure and end stage renal disease. DaVita Kidney Care strives to improve patients' quality of life by innovating clinical care, and by offering integrated treatment plans, personalized care teams and convenient health-management services. As of Dec. 31, 2014, DaVita Kidney Care operated or provided administrative services at 2,179 outpatient dialysis centers located in the United States serving approximately 173,000 patients. The company also operated 91 outpatient dialysis centers located in 10 countries outside the United States. DaVita Kidney Care supports numerous programs dedicated to creating positive, sustainable change in communities around the world. The company's leadership development initiatives and social responsibility efforts have been recognized by Fortune, Modern Healthcare, Newsweek and WorldBlu. For more information, please visit DaVita.com.
DaVita and DaVita HealthCare Partners are trademarks or registered trademarks of DaVita HealthCare Partners Inc.
Contact Information
Media:
Justin Forbis
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
303-876-7496
May 04, 2015
Recipients of AKI kidneys have patient and graft survival rates similar to those of recipients of non-AKI kidneys.
PHILADELPHIA—Transplanted kidneys from deceased donors with acute kidney injury (AKI)are associated with patient and graft survival rates similar to those of non-AKI deceased-donor kidneys, according to study findings presented at the 2015 American Transplant Congress.
Carlo B. Ramirez, MD, of Thomas Jefferson University Hospital in Philadelphia, and colleagues compared outcomes from 65 transplanted kidneys from a donor with AKI with the transplant outcomes of 62 expanded criteria donor (ECD) kidneys and 270 standard criteria donor (SCD) kidneys. The researchers defined AKI as a donor terminal creatinine level of 2 mg/dL or higher.
The 6-month and 1- and 3-year patient survival rates were 98.5%, 96.8%, and 92% in the AKI group, 98.1%, 97%, and 93.4% in the SCD group, and 98.4%, 93.2%, and 77.7% in the ECD group, respectively.
The 6-month and 1- and 3-year death-censored graft survival rates were 96.9%, 96.9%, and 96.9% in the AKI group, 97.7%, 96.5%, and 91.8% in the SCD group, 95.1%, 93.2%, and 90.1% in the ECD group, respectively.
In addition, results showed that AKI kidneys are associated with a higher risk of delayed graft function (DGF) than non-AKI kidneys (58.5% vs. 41.5%) as well as longer cold ischemia time (857.79 vs. 589.32 minutes) and younger donor age (32.25 vs. 40.65 years).
“Elevated terminal donor creatinine is not a risk factor for graft loss after deceased donor kidney transplantation,” Dr. Ramirez's group stated in a poster presentation.
Dr. Ramirez told Renal & Urology News that kidney grafts from donors with elevated creatinine due to AKI—with acceptable biopsy results and machine perfusion pump parameters—may be transplanted safely with outcomes similar to those associated with non-AKI kidneys. “The use of these kidneys may help decrease the high discard rates for this type of kidneys that are already in short supply,” Dr. Ramirez said.
In another study presented at the meeting, researchers at New York-Presbyterian/Weill Cornell Medical College in New York led by Meredith J. Aull, PharmD, also demonstrated that transplantation of kidneys from deceased donors with AKI is associated with death-censored graft survival rates similar to those of non-AKI kidneys, but with an increased risk of DGF. Dr. Aull's group examined outcomes from 688 deceased donor kidney transplants. They defined AKI as a terminal donor creatinine level of 2.0 mg/dL or higher. The researchers broke donors down into 4 groups: (1) ECD with a terminal creatinine level below 2 mg/dL; (2) ECD with a terminal creatinine level of 2 mg/mL or higher; (3) SCD with a terminal creatinine level below 2 mg/dL; and (4) SCD with a terminal creatinine level of 2 mg/dL or higher.
The 3-year death-censored graft survival rates were similar among groups 1–4: 83.3%, 79%, 88.6%, and 87.4%, respectively. DGF rates were 50% and 37.8% in groups 2 and 4 (the AKI groups), respectively, compared with 40.7% and 27.9% in groups 1 and 3 (the non-AKI groups), Dr. Aull's group reported.
In a poster presentation, the researchers stated that use of deceased-donor organs with AKI is associated with a similar incidence of DGF when compared within ECD and SCD donor types, and the duration of DGF is similar (5–6 days).
“Kidneys from donors with AKI appear to be an important resource for the transplant community that is not fully maximized, given the high discard rates,” they concluded.
Movement to expand dialysis unit gaining momentum - Goderich Signal Star
The band is back together.
In 1995, a group of community members banded together to bring a dialysis unit to Alexandra Marine and General Hospital in Goderich.
The unit was opened successfully in 1999.
Twenty years later the group is back in action in hopes of having the unit expanded.
John Grace, who spearheaded the Dialysis ’95 campaign, said they have been asked by patients to jump into action again.
Grace said there are currently about 10 patients in Goderich and area who have to travel to London for dialysis treatment; seven of whom he said qualify to receive treatment at satellite unit such as the one at AMGH.
Traveling to London can be a stressful and trying routine for the patients, Grace explained.
“These patients are very sick, with some being double amputees or having all sorts of other conditions,” he said. “To do that trip is really hard on their physical well being.”
A community meeting regarding the possibility of expanding AMGH’s dialysis unit was held last week in Goderich.
Grace said it was an overwhelming success, with about 70 people in attendance, including patients, advocates, health care workers and representatives from local service clubs who played an integral part in the success of Dialysis ’95.
Speakers included Karen Davis, president and CEO of AMGH and Janice McCallum, director of renal services at London Health Sciences Centre (LHSC) and regional director of the Southwest LHIN.
“This is not strictly a Goderich issue as LHSC administrates the dialysis units in this part of southwestern Ontario,” Grace said, calling the success of the meeting “six steps forward” in the right direction.
“This meeting was really the mountain we had to climb,” he said. “There was overwhelming support. I’m really pleased with how the community has rallied around this. It has been percolating for the last year or so. A lot people know we have an issue.”
The biggest issue facing expansion of the unit is financial constraints, Grace said.
The unit is funded by the Southwest Renal Network in conjunction with the South West LHIN.
“We have the space, we just need some funding from the Goderich hospital,” he said.
Coming out of the meeting, Grace is confident that AMGH is willing to be part of the solution.
“Karen Davis made a firm commitment to work towards making this happen,” he said.
The dialysis unit at AMGH currently serves 12 patients.
The hope is for the unit to be able to handle 18 to 24 patients.
It currently operates three days a week – Grace said they would like to see that increase to six days a week.
Whatever the future holds, Grace said everyone is ready to make it happen.
“There may be some fundraising towards capital investments, such as new equipment,” Grace said. “We are confident we can raise necessary funds.”
There was approximately $200,000 raised during the Dialysis ’95 campaign.
Anyone interested in getting involved can contact Grace or Brenda Teichert.
Old Age Need Not Rule Out Renal Transplants - Renal and Urology News
May 03, 2015
New findings show that even patients in their 80s can benefit.
PHILADELPHIA—Renal transplantation is a viable option even for end-stage renal disease patients in their 80s, according to study findings presented at the 2015 American Transplant Congress.
In a retrospective study, researchers at the University of Maryland Medical Center in Baltimore examined outcomes of 30 kidney transplant recipients in their 80s (mean age 83 years at the time of transplantation). Patient survival rates at 6 months and 1 and 3 years post-transplant were 86.2%, 84.6%, and 66.7%, respectively. The median follow-up time post-transplant was 2 years when censored for early death in the post-operative period. At the last follow-up, 24 patients (80%) had functioning grafts.
Of the 30 patients, 3 (10%) received a living donor kidney, 10 (33%) received a standard criteria donor kidney, 12 (40%) received an expanded criteria donor kidney, and 2 (7%) received a kidney from a donor who suffered a cardiac death.
“In carefully selected recipients, renal transplantation after the age of 80 remains a viable option,” the authors concluded.
Log in to explore the world's most comprehensive database of dialysis centres for free! 
Professional dialysis recruitment
http://photos.prnewswire.com/prnh/20140318/DC85712LOGO
