Monthly Archives: December 2011

ALTITUTE trial of aliskiren on top of ACE or ARB discontinued on DSMB recommendation

Dec 20, 2011 Shelley Wood from heartwire Basel, Switzerland – An increase in adverse events and no apparent benefits among patients randomized to aliskiren (Rasilez/Tekturna, Novartis) in the ALTITUDE trial has prompted the data safety and monitoring board (DSMB) for … Continue reading

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The FNIH Biomarkers Consortium Launches Project to Improve Diagnosis of Kidney Injury

Bethesda, MD (November 1, 2011) – The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium announced today the launch of a two-year clinical study aiming to advance the acceptance of new biomarkers designed to detect drug-induced kidney injury … Continue reading

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STAT3 as a possible new drug target for polycystic kidney disease

Two discoveries at UC Santa Barbara point to potential new drug therapies for patients with kidney disease. The findings are published in this week’s issue of the Proceedings of the National Academy of Sciences. Over 600,000 people in the U.S., … Continue reading

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Affymax’s peginesatide one step closer to FDA approval

The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted 15 to one, with one abstention, that peginesatide (formerly known as Hematide), demonstrated a favorable benefit/risk profile for use in the treatment of dialysis patients with anemia due … Continue reading

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The NIH Conference: Impact of Chronic Kidney Disease, opportunities for randomized clinical trials

On July 19 and 20, I attended a conference and workshop organized by the NIH, entitled “Reducing the Impact of Chronic Kidney Disease, opportunities for randomized clinical trials”. It was attended by over 150 people representing academic nephrologists, NIH, FDA, … Continue reading

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Use of Biomarkers in Renal Diseases

1. BACKGROUND AND INTRODUCTION Traditional risk factors for CV disease (CVD) derived from the Framingham Heart Study do not predict all deaths due to cardiovascular events or stroke [Stenvinkel P 2006]. Biomarkers can supplement the information provided by traditional risk … Continue reading

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