The identification of 20 genes which could help explain the causes of kidney disease could one day “revolutionise” treatment, researchers say.

Chronic kidney disease affects about one in 10 adults and can require dialysis or even an organ transplant.

The genes identified by the international team of researchers control kidney functions such as filtering waste from the blood.

Experts said the Nature Genetics study was “a great breakthrough”.

Chronic kidney disease (CKD) is a long-term condition in which the kidneys progressively lose their function.

People tend not to notice symptoms, which can include swollen ankles and hands or blood in the urine, until the condition is advanced.

It is linked to ageing – about one in five men and one in four women aged between 65 and 74 will have some degree of CKD.

The most common cause of CKD is damage caused by other long-term conditions, such as diabetes and high blood pressure.

It was known there was a genetic component to the disease, but not which genes were involved.

‘First step’

In this study, an international team of scientists, including researchers at the University of Edinburgh, looked at the genes of nearly 70,000 people across Europe.

They found 13 new genes that influence renal function and seven others that affect the production and secretion of creatinine – a chemical waste molecule that is generated from muscle metabolism and filtered through the kidneys.

Dr Jim Wilson, a geneticist at the University of Edinburgh who worked on the study, said: “This work could revolutionise the treatment of kidney disease in the future – but this will take some time.

“It’s a very critical first step towards a completely new understanding of the biology behind CKD. Transferring what we’ve found into clinical benefits will take some years.”

Charles Kernahan, chief executive of the charity Kidney Research UK, said “These are still early days but it is truly a great breakthrough.

“No-one knows who will be affected or when kidney disease may strike next, so even more research needs to be funded to help us tackle this challenge.”

Source: BBC NEWS

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U.S. regulators plan to ask outside experts to re-evaluate the use of Amgen Inc and Johnson & Johnson anemia drugs when given to patients with chronic kidney disease.

Food and Drug Administration officials, in an article published in the New England Journal of Medicine on Wednesday, said the agency “anticipates convening a public advisory committee meeting in 2010 to reevaluate the use of drugs known as erythropoiesis-stimulating agents (ESAs) in people with chronic kidney disease.

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ESAs include Amgen’s Aranesp and Epogen and J&J’s Procrit.

The drugs came under scrutiny after studies showed high doses could lead to heart complications or death. Strong warnings were added in recent years and sales slumped, but the medicines remain widely used for patients with kidney disease and cancer.

FDA spokeswoman Karen Riley said an “important question” for the advisory panel would be what level of hemoglobin doctors should try to achieve with the drugs. The medicines raise levels of oxygen-carrying hemoglobin in the blood.

The FDA officials, in the journal article, said “optimal hemoglobin targets have never been established” for patients with chronic kidney disease.

“Beyond lowering hemoglobin targets and reducing doses of ESAs, it is also possible that more frequent hemoglobin monitoring” and other dosing changes might “improve outcomes” for patients, the FDA officials said.

They said clinical trials had raised “major concerns regarding the use of ESAs to increase hemoglobin concentrations” in chronic kidney disease patients above levels needed to avert blood transfusions.

But the studies “do not rule out the possibility, however, that modest increases in the hemoglobin level could be beneficial,” they added.

Amgen spokeswoman Emma Hurley said the FDA article “highlights areas of incomplete understanding regarding appropriate use” of ESAs in chronic kidney disease.

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The advisory panel meeting will “provide an opportunity to discuss the latest evidence on the benefits and risks” of the medicines, she said.

Centocor Ortho Biotech, the J&J unit that sells Procrit, said in a statement the company “will continue to work with the FDA to ensure that Procrit prescribing information accurately reflects the known benefits and risks of the product, and will continue to communicate this information in a timely fashion.”

Amgen reported third-quarter Aranesp sales of $675 million. Sales of J&J’s Procrit and anemia drug Eprex were $542 million in the quarter.

Source: Reuters

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FDA has removed a 15-month clinical hold on Dynavax Technologies’ HBV vaccine, Heplisav™. The firm is still not allowed to test the candidate in healthy volunteers but has been given the go-ahead for a Phase III trial in individuals with chronic kidney disease.

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The news propelled Dynavax’ stock almost 67% to open trading today at $2.92. In the past year and a half or so, the firm’s value had depreciated over 103% and reached an all time low of $0.16 in November 2008.

The placement of the clinical hold in March of last year sent the company’s share price down 64% in the first week of trading; it went from $5.95 on March 14 to $2.12 by March 20. Then in October 2008 the FDA confirmed that Heplisav was not safe to be tested in healthy people, keeping the company’s share price below $0.50 for the next couple of months.

The agency noted in October the possibility of evaluating the vaccine in those with renal failure, but that was not enough to keep partner, Merck & Co., in tow. By December 2008, Merck had pulled out of the collaboration, sending Dynavax’ stock spiraling downward again by 28% in the first day of trading. Dynavax could have earned $105 million in milestones under the arrangement with Merck over and above the $31.5 million up-front fee.

Now Dynavax says that it will initiate a Phase III study in chronic kidney disease patients in the near-term. The aim is to test Heplisav for its ability to provide increased, rapid protection with fewer doses than current vaccines. Heplisav combines hepatitis B surface antigen with a toll-like receptor 9 agonist to enhance the immune response.

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The company is also planning another Phase III lot-to-lot consistency trial in adults over 40 years in early 2010. It says that its global strategy, which is based on discussions with FDA and EMEA, is to develop the HBV vaccine for populations that less responsive to current vaccines, including those over 40 years and others.

Source: GEN News

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Genzyme announced that the company obtained approval in the EU to market the tablet and powder formulations of Renvela (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease (CKD), including certain patients not on dialysis. Dan Regan, general manager of Genzyme’s renal business, stated that the marketing authorisation “is the first phosphate binder for patients not on dialysis approved through the centralised procedure in Europe.”

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In the US, Renvela’s tablet formulation is already approved for use in patients with CKD on dialysis, and Genzyme anticipates FDA approval of the powder formulation for this indication in the second half of 2009. The company has also been in discussions with the FDA regarding the treatment of hyperphosphataemic CKD patients not on dialysis, and expects the talks to continue beyond midyear.

The drugmaker is also seeking approval for Renvela in other countries and the company noted that the product was approved last week in Brazil to treat patients with CKD on dialysis.

Source: FirstWord

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