Author Archives: admin

Merck Provides Update on REVEAL Outcomes Study of Anacetrapib

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study of anacetrapib met its primary endpoint, significantly reducing major … Continue reading

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

New drugs to treat anemia of chronic kidney disease

Anemia is a major complication in patients with CKD, starting in pre-dialysis stages and worsening with worsening renal function and as dialysis is initiated.  It can result in significant morbidity and impact quality of life.  Current treatments include erythropoiesis stimulating … Continue reading

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

FDA Endocrinologic and Metabolic Drugs Advisory Committee recommends approval of dapagliflozin for the treatment of type 2 diabetes in adults

Today, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 10-4 in favor of the updated cardiovascular risk profile of the investigational sodium-glucose co-transporter 2 inhibitor, dapagliflozin. The committee also voted 13-1 in favor of the agent as an adjunct … Continue reading

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

Combined ACE inhibition and angiotensin receptor blockade shows no advantage over single agent RAS inhibition in patients with diabetic nephropathy: VA-Nephron D study

The results of the recently completed VA-Nephron D study were presented at a Late Breaking Abstract Session at the ASN-Kidney Week and simultaneously published in the New England Journal of Medicine.  The study randomized 1448 type 2 diabetic patients half … Continue reading

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

FDA Advisory Committee recommends against approval of Tolvaptan for polycystic kidney disease

As noted in a previous posting, Tolvaptan, a vasopression type-2 receptor antagonist, currently approved for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, is also being developed for the treatment of autosomal dominant polycystic kidney disease (ADPKD).  Otsuka pharmaceuticals … Continue reading

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

Overcoming obstacles for successful clinical trials in kidney disease

Introduction The incidence and prevalence of chronic kidney disease (CKD) has been increasing, led by diabetes (DM) and hypertension (HTN) that are consequences of poor lifestyle and dietary habits (see USRDS 2012). Although effective treatments are available for both DM and … Continue reading

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

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

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

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

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

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

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

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

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