Author Archives: admin

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

Posted in Kidney-disease-drug-development | Leave a comment

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

Posted in M Loghman-Adham, MD | Leave a comment

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

Posted in M Loghman-Adham, MD | Leave a comment

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

Posted in M Loghman-Adham, MD | Leave a comment

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

Posted in M Loghman-Adham, MD | Leave a comment

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

Posted in M Loghman-Adham, MD | Leave a comment

Nephrotoxicity During Drug Development

A new review of this subject entitled Detection and Management of Nephrotoxicity during Drug Development has been recently published in Expert Opinion on Drug Safety. The article has been available ahead of print on-line since May 22, 2012.  The authors are … Continue reading

Posted in Kidney-disease-drug-development | Leave a comment

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

Posted in M Loghman-Adham, MD | Tagged , , , | Leave a comment

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

Posted in Laboratory tests | Tagged , | Leave a comment

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

Posted in M Loghman-Adham, MD | Tagged , , | Leave a comment