From Washington Post, Opinion: By Marcello Tonelli and John Gill
Marcello Tonelli is associate vice president of research at the University of Calgary. John Gill is a clinician scientist and professor of medicine at the University of British Columbia and a member of the board of directors for the American Society of Transplantation. They are both former presidents of the Canadian Society of Nephrology.
Kidney transplants are universally acknowledged as the best treatment for kidney failure. Compared with remaining on dialysis, transplant recipients live longer, have better quality of life, are more likely to raise a family, have fewer symptoms and incur far fewer health-care costs.
After a successful transplant, keeping the kidney functional requires lifelong use of immunosuppressive medications, which prevent the recipient’s body from rejecting the new organ. These medications provide excellent value for money since they allow the patient and society to reap the benefits of kidney transplantation.
As researchers from Canada, we’ve studied health care for those affected by kidney disease in the United States and other developed nations. Since 1972, Medicare has provided coverage to patients with kidney failure, regardless of age or disability status. However, while there is no time limit for dialysis patients, kidney transplant recipients who are not otherwise eligible for Medicare lose their coverage 36 months after they receive their transplant — leaving many unable to pay for immunosuppressive medications. Without access to these medications, patients eventually lose their transplants and require dialysis treatment instead.
This policy is irrational, since Medicare has already paid for the kidney transplant and will pay to treat the patient with dialysis — despite its markedly higher cost — when the transplanted kidney fails.
Our research has shown the United States stands alone in allowing this situation to exist. All other wealthy nations recognize the benefits of immunosuppressive medications and cover their costs for patients with functioning kidney transplants.
Funding these medications would save hundreds of millions of dollars annually in direct medical costs. Between 2008 and 2012, the most recent data available, the average annual Medicare cost for a transplant recipient was $22,000 compared with $47,000 for a dialysis patient. But those costs are much higher — at $84,000 — for patients who suffered transplant failure and had to return to dialysis. And if you look at only the patients who died after a transplant failure, average costs skyrocket — to $201,000.
Failing to provide lifelong coverage also dishonors the gift of life made by thousands of kidney donors each year, since denying such access means that some of these gifts will be in vain. We estimate that in the past five years, 7,700 patients have needlessly lost their kidney transplants, 900 patients have prematurely died and Medicare has squandered nearly $1 billion in health-care costs that could have been averted if only funding for immunosuppressive medications had been secured.
Even more frustrating, a legislative remedy — commonly known as “the immunosuppression bill” — is already available. Lawmakers first proposed the bill in 2011, but it has repeatedly stalled.
This bill would allow Medicare-eligible kidney transplant recipients to receive life-saving immunosuppressive medications for as long as their transplant continues to function. Ironically, failure to pass this bill into law during the Obama administration may in part be due to its bipartisan support, which gave little political advantage to passing it.
It is impossible to justify continued inaction: The problem and its solution are both straightforward. The machinery required to fund, prescribe and deliver immunosuppressive medications is in place. All that is needed is the political will to pass legislation and allow U.S. patients to benefit.
Kidney transplants are universally acknowledged as the best treatment for kidney failure. Compared with remaining on dialysis, transplant recipients live longer, have better quality of life, are more likely to raise a family, have fewer symptoms and incur far fewer health-care costs.
After a successful transplant, keeping the kidney functional requires lifelong use of immunosuppressive medications, which prevent the recipient’s body from rejecting the new organ. These medications provide excellent value for money since they allow the patient and society to reap the benefits of kidney transplantation.
As researchers from Canada, we’ve studied health care for those affected by kidney disease in the United States and other developed nations. Since 1972, Medicare has provided coverage to patients with kidney failure, regardless of age or disability status. However, while there is no time limit for dialysis patients, kidney transplant recipients who are not otherwise eligible for Medicare lose their coverage 36 months after they receive their transplant — leaving many unable to pay for immunosuppressive medications. Without access to these medications, patients eventually lose their transplants and require dialysis treatment instead.
This policy is irrational, since Medicare has already paid for the kidney transplant and will pay to treat the patient with dialysis — despite its markedly higher cost — when the transplanted kidney fails.
Our research has shown the United States stands alone in allowing this situation to exist. All other wealthy nations recognize the benefits of immunosuppressive medications and cover their costs for patients with functioning kidney transplants.
Funding these medications would save hundreds of millions of dollars annually in direct medical costs. Between 2008 and 2012, the most recent data available, the average annual Medicare cost for a transplant recipient was $22,000 compared with $47,000 for a dialysis patient. But those costs are much higher — at $84,000 — for patients who suffered transplant failure and had to return to dialysis. And if you look at only the patients who died after a transplant failure, average costs skyrocket — to $201,000.
Failing to provide lifelong coverage also dishonors the gift of life made by thousands of kidney donors each year, since denying such access means that some of these gifts will be in vain. We estimate that in the past five years, 7,700 patients have needlessly lost their kidney transplants, 900 patients have prematurely died and Medicare has squandered nearly $1 billion in health-care costs that could have been averted if only funding for immunosuppressive medications had been secured.
Even more frustrating, a legislative remedy — commonly known as “the immunosuppression bill” — is already available. Lawmakers first proposed the bill in 2011, but it has repeatedly stalled.
This bill would allow Medicare-eligible kidney transplant recipients to receive life-saving immunosuppressive medications for as long as their transplant continues to function. Ironically, failure to pass this bill into law during the Obama administration may in part be due to its bipartisan support, which gave little political advantage to passing it.
It is impossible to justify continued inaction: The problem and its solution are both straightforward. The machinery required to fund, prescribe and deliver immunosuppressive medications is in place. All that is needed is the political will to pass legislation and allow U.S. patients to benefit.
PKD Research
The Latest on Tolvaptan and Kidney Function Decline in Later-Stage ADPKD Patients
Vasopressin promotes kidney-cyst cell proliferation and fluid secretion; thus, suppression of vasopressin or blockade of a vasopressin receptor may reduce cyst burden and thus improve kidney outcomes. Tolvaptan is a competitive vasopressin receptor antagonist with potential therapeutic applications in ADPKD.
Review of Recent Trials on Tolvaptan and ADPKD
In 2012, the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) trial investigators randomly assigned 1445 ADPKD patients with creatinine clearance >60 mL/min and a total kidney volume of 750 mL or higher to receive tolvaptan versus placebo.[1] The trial found that over a 3-year period, total kidney volume increased less in the tolvaptan group (2.8% per year vs 5.5% per year in the placebo group).
Tolvaptan was also associated with slower decline in kidney function per year compared with placebo. However, the tolvaptan group also had greater rates of adverse events related to aquaresis and hepatic abnormalities, which led to a higher discontinuation rate.[1] In a follow-up study, the investigators found sustained beneficial effects with tolvaptan use on estimated glomerular filtration rate (eGFR) 2 years after the completion of TEMPO.[2]
In a recent issue of the New England Journal of Medicine, the authors of the REPRISE (Replicating Evidence of Preserved Renal Function: an Investigation of Tolvaptan Safety and Efficacy in ADPKD) trial studied the effects of tolvaptan on kidney function among ADPKD patients with more advanced kidney disease, defined as eGFR of 25-65 mL/min/1.73 m2 (mean eGFR, 41 mL/min/1.73 m2).[3]
The study had 1496 patients enter a single-blind tolvaptan period. The 1370 patients who were able to tolerate tolvaptan without adverse effects were randomly assigned to receive either tolvaptan (doses of 90-120 mg/day) versus placebo. Randomization was stratified according to baseline eGFR, age of the patient, and total kidney volume.
Overall, characteristics of patients at baseline were balanced between the two groups. Most patients assigned to the tolvaptan group, and who completed the trial, were taking 90 mg morning and 30 mg afternoon doses daily.
At 1 year, the mean change in eGFR (with adjustment for the trial duration for each patient) was -2.34 ± 0.24 mL/min/1.73 m2 in the tolvaptan group compared with -3.61 ± 0.24 mL/min/1.73 m2 for the placebo group, which was statistically significant. Overall, the difference in eGFR decline at 1 year between the groups was 1.27 mL/min/1.73 m2. Per the investigators, a change of this magnitude could potentially extend time to ESRD from 6.2 to 9 years in this population.
When examining subgroups, the beneficial effect of tolvaptan on eGFR change was not statistically significant among patients >55 years of age, those who were not white, or those with stage 2 chronic kidney disease (CKD).
It should be noted that the rates of serious adverse effects were higher in the tolvaptan group (12.5% vs 8.8%), and rates of liver-related events were particularly high (10.9% vs 5.3%). The discontinuation rate of the study drug was also higher in the tolvaptan group (9.5% vs 2.2%).
Findings From the REPRISE Trial—Where Do We Stand?
So what does this trial tell us? The findings from REPRISE suggest that among a younger population of ADPKD patients with moderate CKD, who could tolerate tolvaptan without an unacceptable level of side effects, there was a net difference in eGFR decline of 1.27 mL/min/1.73 m2 over 1 year compared with patients taking placebo.
A significant limitation in the study design was the use of a continuous eGFR outcome (which is "noisy" and can be less precise) rather than a "hard" outcome such as 50% decline in eGFR or ESRD. It remains to be seen whether the benefit is sustained after 1 year and whether tolvaptan affects total kidney volume. Finally, the overall risks (in terms of tolerability and adverse effects) versus benefits will need to be carefully considered before starting tolvaptan in patients with late-stage ADPKD.
From Journal of American Physiology Society, by Lisa M. Guay-Woodford
Murine models of polycystic kidney disease: molecular and therapeutic insights
Abstract
Numerous murine (mouse and rat) models of polycystic kidney disease (PKD) have been described in which the mutant phenotype results from a spontaneous mutation or engineering via chemical mutagenesis, transgenic technologies, or gene-specific targeting in mouse orthologs of human PKD genes. These murine phenotypes closely resemble human PKD, with common abnormalities observed in tubular epithelia, the interstitial compartment, and the extracellular matrix of cystic kidneys. In both human and murine PKD, genetic background appears to modulate the renal cystic phenotype. In murine models, these putative modifying effects have been dissected into discrete factors called quantitative trait loci and genetically mapped. Several lines of experimental evidence support the hypothesis that PKD genes and their modifiers may define pathways involved in cystogenesis and PKD progression. Among the various pathway abnormalities described in murine PKD, recent provocative data indicate that structural and/or functional defects in the primary apical cilia of tubular epithelia may play a key role in PKD pathogenesis. This review describes the most widely studied murine models; highlights the data regarding specific gene defects and genetic modifiers; summarizes the data from these models that have advanced our understanding of PKD pathogenesis; and examines the effect of various therapeutic interventions in murine PKD.
Breath test could provide non-invasive detection of kidney failure
Numerous murine (mouse and rat) models of polycystic kidney disease (PKD) have been described in which the mutant phenotype results from a spontaneous mutation or engineering via chemical mutagenesis, transgenic technologies, or gene-specific targeting in mouse orthologs of human PKD genes. These murine phenotypes closely resemble human PKD, with common abnormalities observed in tubular epithelia, the interstitial compartment, and the extracellular matrix of cystic kidneys. In both human and murine PKD, genetic background appears to modulate the renal cystic phenotype. In murine models, these putative modifying effects have been dissected into discrete factors called quantitative trait loci and genetically mapped. Several lines of experimental evidence support the hypothesis that PKD genes and their modifiers may define pathways involved in cystogenesis and PKD progression. Among the various pathway abnormalities described in murine PKD, recent provocative data indicate that structural and/or functional defects in the primary apical cilia of tubular epithelia may play a key role in PKD pathogenesis. This review describes the most widely studied murine models; highlights the data regarding specific gene defects and genetic modifiers; summarizes the data from these models that have advanced our understanding of PKD pathogenesis; and examines the effect of various therapeutic interventions in murine PKD.
Kidney Failure Detection
From WINK-TV, Southwest Florida
It is one of the top ten leading causes of death and affects five million people in the U.S. Now, doctors at the Cleveland Clinic are testing a new, non-invasive way to detect kidney failure.
Doctors can test your blood and urine for diseases, but now a new device is allowing them to test your breath.
Raed Dweik, MD, Director of Pulmonary Vascular Program at Cleveland Clinic explained, “If you can do it at the side of the road, you can do it anywhere.”
He believes that you can see the health of a patient through their breathprint.
“Anything that is potentially volatile in our blood comes up in the lung and can be measured in exhaled breath,” continued Dr. Dweik. Such as kidney failure.
A healthy kidney gets rid of wastes and toxins in a person’s blood. When the kidneys are not functioning properly, they can cause kidney stones and possibly death. Dr. Dweik and his team are trying to prevent this, by testing for kidney failure using a breathalyzer. In a study of patients with kidney failure and healthy volunteers, he was able to identify five volatile organic compounds in the breath of patients with kidney failure. The device is still being analyzed before it goes to clinical trials.
Researchers also plan to study the effects of dialysis on kidney failure patients’ breathprint. Dr. Dweik has worked on other breath test studies as well, developing breath tests for asthma, heart failure, liver disease, and obesity.
BACKGROUND
Ten percent of the population worldwide is affected by chronic kidney disease (CKD), and millions die each year because they do not have access to affordable treatment. Over 2 million people worldwide currently receive treatment with dialysis or a kidney transplant to stay alive. High blood pressure and diabetes are the main causes of CKD. Almost half of individuals with CKD also have diabetes and/or self-reported cardiovascular disease. More than 661,000 Americans have kidney failure and of those, 468,000 individuals are on dialysis and roughly 193,000 live with a functioning kidney transplant. Kidney disease often has no symptoms in its early stages and can go undetected until it is very advanced. This is the reason it is often referred to as a “silent disease.” Each year, kidney disease kills more people than breast or prostate cancer. In 2013, more than 47,000 Americans died from kidney disease.
CURRENT TREATMENTS
If your kidneys can’t keep up with waste and fluid excretion on their own and you develop complete or near-complete kidney failure, you have end-stage kidney disease. At this point, dialysis or a kidney transplant is recommended. Dialysis artificially removes waste products and extra fluid from your blood when your kidneys can no longer do this. A kidney transplant involves surgically placing a healthy kidney from a donor into your body. The patient will need to take medications for the rest of his/her life to keep the body from rejecting the new organ. For some who choose not to have dialysis or a kidney transplant, a third option is to treat kidney failure with conservative measures. There has been recent development of a disease-detecting breathalyzer that can potentially identify 17 different diseases. “One of the major challenges in the modern era of disease diagnosis is how we can detect the disease when we are still feeling healthy,” says Hossam Haick of the Technion-Israel Institute of Technology. This device is capable of catching a disease in the early stages and may even be able to predict people that are at high risk for certain conditions. Researchers identified more than 100 other chemical compounds exhaled in each breath, 13 of which were associated with certain diseases.
BREAKTHROUGH RESEARCH
Researchers at the University of Washington Health Sciences/Medicine are creating and manipulating mini-kidney organoids that contain a realistic micro-anatomy that tracks the early stages of polycystic kidney disease (PKD). The organoids are grown from human stem cells. By substituting certain physical components in the organoid environment, cyst formation can be increased or decreased. The team found that PKD mini-kidneys grown in free-floating conditions formed hollow cysts that were very large. These cysts could easily be seen. In contrast, PKD mini-kidneys attached to plastic dishes stayed small. According to Nelly Cruz, research scientist, other manipulations to the organoid affects the progression of the disease. “We’ve discovered that polycystin proteins, which are causing the disease, are sensitive to their micro-environment. Therefore, if we can change the way they interact or what they are experiencing on the outside of the cell, we might actually be able to change the course of the disease.”
PKD Life
From Auburn Journal
Auburn resident gets award for giving back
After receiving a kidney transplant 15 years ago, one Auburn resident was chosen for a national award.
Valen Keefer was chosen for the Bounce Back Give Back award from the Chris Klug Foundation, an award for people who live exceptional lives post transplant.
The awards recognize two transplant recipients who exhibit an exceptional post-transplant quality of life, whether it is a career accomplishment, participation in a sport or hobby, or simply leading a fulfilling life with family and loved ones.
“There is something very touching and serendipitous to all of this,” Keefer said. “I was just diagnosed with a rare autoimmune disease — primary sclerosing cholangitis (PSC). This disease, in which there is no treatment or cure, is the same disease that Chris Klug has that led to him needing a liver transplant and will ultimately lead to me needing a liver transplant, too. I was diagnosed with PSC after being selected for this award. The opportunity to meet Chris could not have come at a better time in my life.”
More than 65 nominations representing individuals from 24 states were received for this year’s awards. A team of CKF reviewers selected the two award winners. The two honorees and one guest each will enjoy an all-expense-paid trip to Aspen for the award ceremony on Dec. 8.
Keefer has demonstrated a commitment to spreading the word about polycystic kidney disease (PKD) and advocating for organ transplantation, while honoring her donor.
After being diagnosed with PKD at age 10, Keefer battled serious health complications until receiving a lifesaving kidney transplant at age 19. Since that time, she has dedicated her life’s work to being an ambassador for the cause.
As a blog writer for the PKD Foundation Keefer has published more than 210 articles. She is a founding committee member of the Sacramento chapter of the PKD Foundation, Corks for a Cure event and has spoken at more than 90 different gatherings, reaching thousands of people. Awarded the 2012 Outstanding Media Ambassador for Sierra Donor Services, Keefer’s efforts include an extensive list of volunteer and professional accomplishments including being the subject of an award-winning biography and selected as one of the 12 Most Inspiring Women of “20 Million in 2012” by Donate Life America.
“I believe we can always find the good in life and I hope you’ll help me spread my message of positivity, this award announcement, and also the beauty of the gift of life with your readers,” Keefer said. “Despite all of the health challenges I face, I continue to bounce back and give back through it all. “
Doctors can test your blood and urine for diseases, but now a new device is allowing them to test your breath.
Raed Dweik, MD, Director of Pulmonary Vascular Program at Cleveland Clinic explained, “If you can do it at the side of the road, you can do it anywhere.”
He believes that you can see the health of a patient through their breathprint.
“Anything that is potentially volatile in our blood comes up in the lung and can be measured in exhaled breath,” continued Dr. Dweik. Such as kidney failure.
A healthy kidney gets rid of wastes and toxins in a person’s blood. When the kidneys are not functioning properly, they can cause kidney stones and possibly death. Dr. Dweik and his team are trying to prevent this, by testing for kidney failure using a breathalyzer. In a study of patients with kidney failure and healthy volunteers, he was able to identify five volatile organic compounds in the breath of patients with kidney failure. The device is still being analyzed before it goes to clinical trials.
Researchers also plan to study the effects of dialysis on kidney failure patients’ breathprint. Dr. Dweik has worked on other breath test studies as well, developing breath tests for asthma, heart failure, liver disease, and obesity.
BACKGROUND
Ten percent of the population worldwide is affected by chronic kidney disease (CKD), and millions die each year because they do not have access to affordable treatment. Over 2 million people worldwide currently receive treatment with dialysis or a kidney transplant to stay alive. High blood pressure and diabetes are the main causes of CKD. Almost half of individuals with CKD also have diabetes and/or self-reported cardiovascular disease. More than 661,000 Americans have kidney failure and of those, 468,000 individuals are on dialysis and roughly 193,000 live with a functioning kidney transplant. Kidney disease often has no symptoms in its early stages and can go undetected until it is very advanced. This is the reason it is often referred to as a “silent disease.” Each year, kidney disease kills more people than breast or prostate cancer. In 2013, more than 47,000 Americans died from kidney disease.
CURRENT TREATMENTS
If your kidneys can’t keep up with waste and fluid excretion on their own and you develop complete or near-complete kidney failure, you have end-stage kidney disease. At this point, dialysis or a kidney transplant is recommended. Dialysis artificially removes waste products and extra fluid from your blood when your kidneys can no longer do this. A kidney transplant involves surgically placing a healthy kidney from a donor into your body. The patient will need to take medications for the rest of his/her life to keep the body from rejecting the new organ. For some who choose not to have dialysis or a kidney transplant, a third option is to treat kidney failure with conservative measures. There has been recent development of a disease-detecting breathalyzer that can potentially identify 17 different diseases. “One of the major challenges in the modern era of disease diagnosis is how we can detect the disease when we are still feeling healthy,” says Hossam Haick of the Technion-Israel Institute of Technology. This device is capable of catching a disease in the early stages and may even be able to predict people that are at high risk for certain conditions. Researchers identified more than 100 other chemical compounds exhaled in each breath, 13 of which were associated with certain diseases.
BREAKTHROUGH RESEARCH
Researchers at the University of Washington Health Sciences/Medicine are creating and manipulating mini-kidney organoids that contain a realistic micro-anatomy that tracks the early stages of polycystic kidney disease (PKD). The organoids are grown from human stem cells. By substituting certain physical components in the organoid environment, cyst formation can be increased or decreased. The team found that PKD mini-kidneys grown in free-floating conditions formed hollow cysts that were very large. These cysts could easily be seen. In contrast, PKD mini-kidneys attached to plastic dishes stayed small. According to Nelly Cruz, research scientist, other manipulations to the organoid affects the progression of the disease. “We’ve discovered that polycystin proteins, which are causing the disease, are sensitive to their micro-environment. Therefore, if we can change the way they interact or what they are experiencing on the outside of the cell, we might actually be able to change the course of the disease.”
PKD Life
From Auburn Journal
Auburn resident gets award for giving back
Valen Keefer was chosen for the Bounce Back Give Back award from the Chris Klug Foundation, an award for people who live exceptional lives post transplant.
The awards recognize two transplant recipients who exhibit an exceptional post-transplant quality of life, whether it is a career accomplishment, participation in a sport or hobby, or simply leading a fulfilling life with family and loved ones.
“There is something very touching and serendipitous to all of this,” Keefer said. “I was just diagnosed with a rare autoimmune disease — primary sclerosing cholangitis (PSC). This disease, in which there is no treatment or cure, is the same disease that Chris Klug has that led to him needing a liver transplant and will ultimately lead to me needing a liver transplant, too. I was diagnosed with PSC after being selected for this award. The opportunity to meet Chris could not have come at a better time in my life.”
More than 65 nominations representing individuals from 24 states were received for this year’s awards. A team of CKF reviewers selected the two award winners. The two honorees and one guest each will enjoy an all-expense-paid trip to Aspen for the award ceremony on Dec. 8.
Keefer has demonstrated a commitment to spreading the word about polycystic kidney disease (PKD) and advocating for organ transplantation, while honoring her donor.
After being diagnosed with PKD at age 10, Keefer battled serious health complications until receiving a lifesaving kidney transplant at age 19. Since that time, she has dedicated her life’s work to being an ambassador for the cause.
As a blog writer for the PKD Foundation Keefer has published more than 210 articles. She is a founding committee member of the Sacramento chapter of the PKD Foundation, Corks for a Cure event and has spoken at more than 90 different gatherings, reaching thousands of people. Awarded the 2012 Outstanding Media Ambassador for Sierra Donor Services, Keefer’s efforts include an extensive list of volunteer and professional accomplishments including being the subject of an award-winning biography and selected as one of the 12 Most Inspiring Women of “20 Million in 2012” by Donate Life America.
“I believe we can always find the good in life and I hope you’ll help me spread my message of positivity, this award announcement, and also the beauty of the gift of life with your readers,” Keefer said. “Despite all of the health challenges I face, I continue to bounce back and give back through it all. “
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