Author Archives: admin

Saxagliptin (Onglyza) fails to reach primary endpoint in a CV outcome study of type 2 diabetic patients

On June 19, 2013 Bristol-Myers Squibb (BMS) announced top-line results of the phase IV study, named SAVOR-TIMI-53. In this study of adult patients with type 2 diabetes with either a history of established cardiovascular disease or multiple risk factors, Onglyza … Continue reading

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Results of Phase 3 clinical trial of ferric citrate (Zerenex) to be presented at the ISN World Congress of Nephrology (WCN)

According to the WCN program (see here), a poster (#SU401) entitled ” Ferric citrate is a novel efficacious phosphate binder” will be presented on June 2nd by Dr. Julia Lewis from Vanderbilt University Medical Center (view abstract) during the Annual … Continue reading

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Abbvie announces initiation of the phase 3 registration trial of atrasentan on renal outcomes in patients with diabetic nephropathy

Atrasentan is a selective endothelin A receptor antagonist,  which was found to have cytostatic properties in prostate cancer (reviewed here) .  Due to promising early results, atresantan was initially developed for the treatment of hormone-refractory prostate cancer (see here).  However, … Continue reading

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Another trial of darbepoetin alfa (Aranesp) shows disappointing results

In 2009 TREAT, a large placebo-controlled trial of darbepoetin alfa, an erythropoiesis stimulating agent (ESA) was conducted in patients with type 2 diabetes who had chronic kidney disease and anemia (see TREAT).  The rationale for the study was that CKD … Continue reading

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The Costs of Clinical Trials and Drug Development

A recent report published in Pharmalot  shows that the cost of conducting clinical trials has risen to staggering figures.  Across all therapeutic areas, the average cost per patient in phase 1 trials rose from $15,023 in 2008 to 21,882 in … Continue reading

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OMONTYS® (peginesatide) recalled due to fatal allergic reactions

On February 23, 2013, Affymax and Takeda announced a voluntary nationwide recall of all lots of Omontys (peginesatide), a peptide mimetic erythropoiesis stimulating agent (ESA), which was approved on March 27, 2012 by the FDA for the treatment of anemia … Continue reading

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Targeted therapy with folate-conjugated rapamycin, a promising treatment for PKD

Autosomal dominant polycystic kidney disease(ADPKD) is a common genetic kidney disease caused by mutations in either PKD1 or PKD2 genes, resulting in the presence of multiple cysts that increase in size and lead to a number of complications, including early-onset … Continue reading

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Trials and tribulations in kidney disease

On November 3, 2012 at the recent meeting of the American Society of Nephrology-Kidney Week  in San Diego, the results of three important clinical trials in nephrology were presented during  a special session on High Impact Clinical Studies. The first … Continue reading

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Phase 3 Clinical Trial of CKD Drug Bardoxolone Halted on Safety Concerns

Reata Pharmaceuticals announced yesterday (Oct 18, 2012) that it has decided to terminate the phase 3 clinical trial of Bardoxolone methyl [BEACON] for treatment of patients with stage 4 kidney disease and type 2 diabetes.  Abbott is co-developing Bardoxolone and … Continue reading

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Calcium-Free Phosphate Binders – Review

This article was originally published in abbreviated form at an Spanish on-line journal [http://www.siicsalud.com/dato/dat048/06406023a.htm].  The attached pdf link is the full version, not published previously.  The article summarizes the issues related to phosphate retention, excess calcium absorption due to the … Continue reading

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