CKD - Dementia Link

Does an impairment in kidney function in the elderly lead to an acceleration in cognitive decline?

It appears so, says the authors of a study published in last week's journal of Neurology.

A prospective observational cohort study of nearly 900 elderly patients with CKD but without dementia was conducted using members enrolled in the Rush Memory and Aging Project. The groups were broken into two. One with an estimated GFR (using MDRD equation) >60 and the other group eGFR <60 ml/min. A battery of 19 cognitive tests were given at time zero to obtain a baseline, then repeated annually.

Indeed, a more rapid decline in cognitive function was associated with a decreased eGFR. It is uncertain whether the etiology of CKD mattered. It would also be interesting to know some data on the blood pressure control within the groups. The study was relatively small, and could be improved upon... but, it is thought provoking.

Renal Denervation for Refractory Hypertension

Compliments of MedPage Today

The Government Can

New Strategy for Renoprotection During Coronary Bypass?

An interesting new study has taken a look at a new approach to protecting the kidney function during a coronary artery bypass (CABG) surgery. The study took place in Japan and was published in a recent issue of the Journal of the American College of Cardiology.



As most nephrologists are keenly aware... acute kidney injury is quite common after CABG and carries a high degree of morbidty and mortality. Any strategy to decrease the risk of post-operative AKI would be welcome.


This study took 504 patient undergoing CABG and split them into 2 groups. One group was given human atrial natriuretic peptide (ANP) at 0.02 mcg/kg/min at the start of cardiopulmonary bypass and the other group received placebo.


Although there was no mortality difference, the group that received the continuous infusion of ANP during the surgery maintained post-op renal function much better with a significantly lower incidence of AKI.


Now... if only human ANP was available in the USA....

New KDIGO Mineral and Bone Disease Guidelines

KDIGO is a global non-profit foundation dedicated to improving the care and outcomes of kidney disease patients worldwide.

New guidelines on bone mineral metabolism in CKD have been released on the KDIGO website and in print by Kidney International.

Disappointing Data from USRS

As reported by Renal Business Today, data has been released by the USRDS (US Renal Data System) for 2007 and some of it is unfortunately pretty disappointing. The report shows that many patients starting ESRD therapy received no nephrologist care, dietary counseling or therapy with erythropoietin-stimulating agents prior to dialysis.

The disappointment lies in the underutilization of nephrologists in the pre-ESRD population. One in three patients who started ESRD therapy in 2007 had seen a nephrologist for a year or less, according to the 2009 USRDS Annual Data Report, which was released Sept. 22. Twenty-four percent of 2007’s new ESRD patients had seen a nephrologist for a longer period of time, and 43 percent had not seen one at all. Furthermore, 90 percent of new patients did not receive any dietary counseling, and 71 percent didn’t receive erythropoietin-stimulating agent therapy.

OTHER STATS:

The ESRD population hit a new high in 2007 with 527,283 patients. 368,544 were on dialysis and 158,739 were transplant patients, according to the USRDS report. That year, 87,812 ESRD patients died.

The number of new cases, however, remained the same between 2006 and 2007 at approximately 111,000. “These data suggest that the prevalent population is living longer, influencing both the growth of the treated ESRD population and the annual expenditures these patients incur,” according to the report.

Total Medicare costs in 2007 were $410 billion, and ESRD spending took up 5.8 percent of Medicare’s budget that year, according to the USRDS report. In absolute dollars, the ESRD program grew 6.1 percent in 2007.

“The expanding size of the ESRD program, and projections that it will double in the next 10 years suggest that the population at risk for kidney disease should be addressed with detection and prevention strategies to reduce the long-term burden of ESRD,” according to the report.

Total ESRD costs were $35.32 billion in 2007. Of that, Medicare spent $23.88 billion on ESRD, which was a 2.6 percent increase over 2006. That same year, Medicare spent $61,768 for each ESRD patient. Breaking that down further, Medicare spent $73,008 on each hemodialysis patient, $53,446 on each peritoneal dialysis patient, and $24,572 on each transplant patient.

Between 2002 and 2007, the number of dialysis units and patients rose 18 percent and 20 percent, respectively. In 2007, the large dialysis organizations—DaVita, Dialysis Clinic Inc. and Fresenius—treated 225,400 patients at 3,127 units, according to the report.

New Phosphorous Binder in Pipeline

Keryx biopharmaceuticals has announced that their new phosphorous binder Zerenex is well tolerated, safe and effective for long term use.

Zerenex (ferric citrate) is an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has recently completed a U.S. Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, and we are in the process of finalizing the U.S. Phase 3 program for Zerenex in consultation with the FDA. Zerenex is also in Phase 2 development in Japan.

Data from the mid-stage trial indicated that Zerenex could maintain phosphorus content at a normal level when used over an extended period of time. The data did not show signs of potential iron overload in the blood. The late-stage study for the kidney drug is expected to begin at the end of the year. More details to follow when available.

Omega 3 FA May Improve Hypertension in CKD

A new study from Australia published in the Journal of Hypertension suggests omega 3 fatty acid supplementation may lead to a decrease in blood pressure as well as a reduction in cardiovascular disease in non-diabetics with moderate to severe chronic kidney disease.

In a double-blind, placebo-controlled intervention, 85 patients (74 completed the study) were randomized to either 4 grams of omega 3FA, 200mg Coenzyme Q10, both, or control for 8 weeks.

The study showed that omega 3FA use led to a reduction in blood pressure (-3.3 /- 2.9 +/- 0.7/0.5) , heart rate (-4 +/- 0.5 bpm) and triglycerides (-24%) in patients with CKD. CoQ use caused an increase in heart rate and no change in blood pressure.

New Pre-transplant Benefit of Dopamine?

The renal benefit of exogenous dopamine use has been controversial and largely disappointing in clinical practice. The theoretic improvement promised by the low-dose ("renal dose") dopamine has not played out and has been refuted... despite its continued interest in critical care medicine throughout the country.

Another novel use of Dopamine shows a new potential benefit in a study detailed in a recent issue of JAMA. The study shows a reduction in the need for dialysis post-renal transplant with use of pre-transplant low- dose Dopamine in brain-dead patient donors. It is assumed this would translate into a better long term outcome for deceased donor transplant recipients. The mechanism of the protection offered by dopamine is thought to be from limiting the organ injury from cold preservation.

An Easy Cut to US Health Care Spending?

The RAND corporation reports a study detailed in yesterday's New York Times about a significant health care saving strategy, which may be a surprise to some.

Mr. Obama, want to save 18 billion in health care spending without incurring any extra cost? Sounds great, huh? What is this secret strategy? Influence the decrease in US salt consumption.

Currently, the average salt intake in the USA is 3400 milligrams. The RAND study showed that cutting back to the recommended goal of 2300 milligrams could reduce the incidence of hypertension by 11 million cases. 18 billion may even be somewhat conservative as improvements in quality of life and the possibility of regained workdays are hard to quantify. Nevertheless, some economists believe the savings can total an extra $32 billion. Yes, that is billion with a "b".

ASN's Kidney News Podcast

I guess I missed this, and was happy to be made aware of this resource by my friend, Dr Nathan Hellman at the must read nephrology blog, Renal Fellow Network.

As opposed to the mind numbingly dull NephSAP podcasts, the ASN is sponsoring a series of more stimulating, interactive and easily digestible Kidney News Podcasts.

You can check in at the ASN website for the updates. The latest is an interview with the well known nephrologist, Dr Richard Glassock regarding the pros and cons of the widespread use of eGFR. I encourage everyone to sign up for a free subscription to the podcast as I have through iTunes.

Can We Cut Down on the Bed Rest After a Renal Biopsy?

According to a small Japanese study published in Clinical and Experimental Nephrology, the answer is yes. It appears a shorter period of strict bed rest after a renal biopsy is safe can also decrease patient discomfort post-procedure.

The study examined 94 consecutive patients undergoing a native renal biopsy at a hospital in Japan. The authors concluded that shortening the period of strict bed rest after renal biopsy from 7 hrs to 2 hrs decreased the incidence of back pain, but there was no increase in bleeding or other biopsy-related complications. The HMOs will be thrilled.

FDA Approves New Combination Hypertension Pill

The FDA approves VALTURNA ... this will be the newest in the increasingly long string of combination anti-hypertensive pills. Combination pills have become all the rage in recent years. The ease of taking two medications or more (Exforge HCT has three components) in a single pill improves potency as well as compliance.

Valturna, is the latest offering from Novartis. It is a combination of their blockbuster angiotensin receptor blocker (ARB), Diovan (valsartan) and the newer but significantly less successful direct renin inhibitor, Tekturna (aliskiren).

This will be the first combination pill with both components acting on the renin-angiotensin-aldosterone axis. Maximizing the RAS blockade has long been a strategic goal in the field of hypertension and nephrology. Unfortunately, the once promising combination of an ARB with an ACE inhibitor has yielded conflicting and largely disappointing results. Nevertheless, there is some decent data with adding on aliskiren particular in regards to proteinuria. The combo pill, Valturna may be of use in the CKD world in patients with at least modest proteinuria. But overall, Valturna will likely be a niche player in the hypertension universe.

How long do you think it will take to see Valturna HCT?

Self Diagnosis for Kidney Disease?

By Rachel Berman, RD, CSR, CDN, VP of Operations for SkinnyandtheCity.com

You can do everything on the internet these days: buy groceries, pay your bills, and even diagnose yourself with a life-threatening disease. Well, not exactly. But credible information from the internet can help people identify risk factors for serious clinical conditions and help guide them through the treatment they need.

An article in the New York Times this week documented one woman’s journey as she changed the course of her life with information she got from the web. Two different doctors could not explain her weight gain, high blood pressure despite multiple meds and elevated creatinine, so when she saw an advertisement for a free screening from the National Kidney Foundation, she jumped on the chance. About nine years ago, the NKF founded an initiative called KEEP (Kidney Early Evaluation Program) which is still going strong nationwide.

KEEP was started because family practice doctors and internists are not necessarily calculating estimated GFR (glomular filtration rate) even when a patient shows multiple signs of kidney disease such as high blood pressure, increased creatinine, and repeated kidney infections. This program, which has so far examined 130,000 participants, screens those with common kidney disease risk factors. In fact, half of the first 11,000 tested had evidence of kidney disease but only about 3% knew that beforehand.

This patient discovered that indeed her GFR was 49, a sign of a more chronic kidney problem. Can you blame her for not going back to those doctors for treatment? Instead, she turned to the internet and made changes on her own with regards to her diet and exercise. She cut out foods high in phosphorus and sodium, started making more wholesome meal choices, and kept to a regular exercise routine. After 6 months, she dropped her excess weight, and her blood pressure and GFR normalized.

Ah, the power of prevention. This rings especially true for lifestyle changes which can slow and actually halt disease progression without need for any medicine at all. Unfortunately, often times we just don’t reach the patient (physically or mentally) early enough whether it’s because of poor socioeconomic status, lack of screening when certain conditions are present, or simply the patient is noncompliant with the treatment for their underlying, kidney-damaging condition. And once these patients require ongoing dialysis or undergo transplantation, billions of dollars are easily added to the nation’s health care costs.

The internet is a powerful tool. In this case, it was able to reach a patient in need, diagnose, educate, and even save money. However, there is a lot of bs to sift through on the web and those with an unfavorable socioeconomic status can’t necessarily reap its benefits. Eventually, will responsible websites replace health care professionals? Perhaps to some small degree. But, even with the most credible information out there, it’s ultimately up to the individual to take responsibility for their own health, seek out professional advice, and take action when necessary.

Outcomes in Acute Kidney Injury Requiring Dialysis in Hospital

Unfortunately it is not uncommon in the hospital to see acute kidney injury (AKI (formerly ARF)).. especially if you are a nephrologist in a busy tertiary care hospital. The severity of AKI can be mild, or can be severe in which case renal replacement may be necessary. The mortality in this patient population is high. But, little is known about the outcome of the patients who survive and are discharge on dialysis.

In the latest JAMA, an orginal contribution from the University of Toronto Acute Kidney Injury Research Group examine this patient population.

The study examined more than 3769 adults with AKI requring dialysis vs 13,598 matched controls. The conclusion revealed that AKI necessitating in-hospital dialysis was associated with an increased risk of chronic dialysis... BUT NOT ALL - CAUSE MORTALITY.

Road Noise and Hypertension Link

How is this for a non-traditional risk factor for hypertension.... road noise!

According to a Swedish study, people living near noisy roads are at a higher risk for high blood pressure.

The study concluded that the risk of hypertension rose when the average daily exposure rose above a decibel level of 60.

Although this is an eye catching study, the reality is that the link between noise and HTN is unlikely to be direct. It is more plausible that other factors such as sleep deprivation and stress are the triggers. Nevertheless, it would be interesting to see this type of study on a larger scale.. even here in New York. Would there be a substantial blood pressure difference (assuming you can eliminate confounding variables) among people living in Manhattan vs. the suburbs?

AAKP Hosting Educational Kidney Program in Brooklyn

The American Association of Kidney Patients (AAKP) has partnered with the Brooklyn Kidney Club of Downstate to host a Kidney Beginnings Live Program this weekend.

Programs last approximately three hours and feature presentations given by health care professionals including topics such as:

• What the kidneys are and how they function
• Managing conditions that lead to CKD
• Side effects and challenges CKD patients face, such as anemia
• Diet management and nutrition

Location:SUNY Downstate Medical Center

Health Science Education Building

Alumni Auditorium

395 Lenox RoadBrooklyn, NY 11203

Date:Sunday, September 13, 2009Time:1:00 p.m. - 4:00 p.m.

For more information, click here.

Acumen Gets PQRI Nod from CMS

The Health IT Services Group (HITSG) announced September 8th that the Centers for Medicare & Medicaid Services (CMS) has approved the Fresenius Medical Care CKD registry, which operates through its Acumen EMR, as a participating registry in CMS's 2009 Physician Quality Reporting Initiative (PQRI).

This will now enable participating nephrologists to report quality outcomes to the PQRI program and therefore qualify for incentive participation payments from CMS, according to HITSG.

"As the largest nephrology-specific EHR (Electronic Health Record) provider, Acumen offers nephrologists the ability to submit their data directly to the Acumen PQRI database which supports multiple reporting options and features," said Terry Ketchersid, MD, vice president and chief medical officer for HIT Services Group and Acumen. "Our background with the PQRI program and the variety of caregiver participation options we offer makes this the leading application for nephrologists wishing to participate in this CMS incentive program."

Should Acumen be the EMR of choice for all nephrologists? I don't see DaVita jumping on board. What about smaller private practice nephrology groups? Will Acumen be expanded for better use in the outpatient office setting? Will other EMRs be able to be tailored to qualify for PQRI? Many more physicians/ groups will be running to sign up soon for an EMR if they haven't already to qualify for the CMS bonus. This will continue to be a hot topic, and it appears Fresenius is the front runner in regards to a Nephrology specific EMR. Surely, there will be more to come on this topic...

Spire Sells Catheter Business for 15M

I guess Spire Corp. is on board with Fistula First.

As reported in Renal Business Today: Spire Corp. has sold their catheter related business interest to Bard Access Systems for a cool $15 million. Bard Access Systems will also receive a license and a sublicense in the field of hemodialysis catheters to use certain intellectual property used by Spire in its Surface Treatment Business, which provides coating and surface modification services primarily to medical device customers.

That sounds like a sizeable sum to me...

Was Amgen's New Anemia Study a Trick or TREAT?

It may be a little early to start thinking about Halloween. But Labor Day, the unofficial end of summer is upon us and Amgen's recently reported study has gotten me in the mood.

So, was Amgen's latest study a trick or a TREAT (Trial to Reduce cardiovascular Endpoints with Aranesp Therapy)?

Apparently the answer is neither. Aranesp did not benefit, nor did it hurt the cardiovascular health of CKD patients with anemia and type 2 diabetes.

This was a well designed randomized double-blind placebo based study of more than 4000 CKD patients making it the largest ESA-CKD study to date.

The study had 2 endpoints:

1) Deaths from any cause or cardiovascular morbidity (CHF, Acute MI, Stroke, hospitalization for myocardial ischemia)

2) Time until death or renal replacement therapy

Patients in the study received Aranesp to a goal hemoglobin of 13 g/dL or placebo. If the Hb dipped below 9 mg/dL patients received Aranesp to keep from not falling too far.

The conclusion: no statistically significant effect on either of two primary endpoints compared with placebo treatment. There was a however, an increase in strokes within the Aranesp group.

Amgen spoke of the trial in a press release with more details to follow. I would like to see the rest of the data and would like to know if there was a quality of life (QoL) assessment analysis. For now it seems the recommendation of keeping the target between 10-12 g/dL is prudent. There was a higher incidence of stroke and no benefit mentioned reaching for a goal hemoglobin of 13 g/dL (?QoL).

1 in 5 Patients with CKD Suffers from Depression

A study just published in the latest issue of the American Journal of Kidney Disease reports perhaps a higher incidence of depression in CKD patients than currently realized. Although this is a large study, it is also from a single center (VA in Dallas, TX) and it is comprised of a skewed population (largely male veterans). Nevertheless, it is important to recognize depression and its high incidence even in the early stages of CKD before renal replacement therapy is necessary.

From the journal, the conclusion: One in 5 patients with CKD had a major depressive episode. Patients with CKD should be screened routinely for depression given this high prevalence and the independent association of depression with poor outcomes in patients with end-stage renal disease receiving maintenance dialysis.

Iraqis Selling Kidneys for Cash : WSJ

H1N1 Rap

This is not kidney related... but, I couldnt resist.

FDA Approves Powder Form of Renvela

Get ready for another phosphorous binding option. The big players (Renagel/Renvela, PhosLo) have been plagued by high pill burden to control the serum phosphorous levels. Fosrenol has its niche but the chewable tablets have been met with a mixed reaction from patients.

Genzyme, the maker of Renvela (and formerly Renagel) has now gotten approval from the FDA for a powdered form the the popular phosphorous binder. The strengths approved were 0.8 grams (similar to the 800 mg Renvela tablet) and 2.4 grams. The 2.4 gram powder form, equivalent to taking three of the current 800 mg tabs is intriguing. They will be marketed in 'little packets' similar to sugar packets. They are designed to be added to a "few ounces" of liquid. Since dialysis patients are on fluid restrictions, the quantity of fluid necessary is of great interest. There will be a citrus-flavoring added.... yum.

It is interesting to see the Genzyme reps, who have been downplaying the appeal of Fosrenol seem now to have jumped on the non-traditional bandwagon. Although the Genzyme reps I have spoken to feel Fosrenol tastes poor and they claim patients get just as tired chewing pills as they do swallowing them... I am anxious to hear more spin on their great tasting fun to ingest new offering.

Fatal Accident at Dialysis Center

This is something that everyone involved with hemodialysis fears, and thankfully almost never happens.... ALMOST never....

Although details are limited, an 81 year old woman from the Chicago area died after a needle dislodged from her dialysis access during a routine treatment. Apparently, she was trying to change her shirt and the needle came out of the fistula (or graft?). She died shortly thereafter as a result of acute blood loss (hemorrhage) leading to cardiopulmonary arrest.

Despite the current policies and procedures in place to avoid such a tragic occurrence we should all be reminded that this can occur. Extreme caution should be practiced and healthcare workers as well as hemodialysis patients need continuing education and reinforcement of the safety protocols to avoid such devastating outcomes.