Nephrogenic systemic fibrosis (NSF) is a rare, serious, and life-threatening disease of patients with severe renal impairment. Gadolinium-containing contrast agents have been shown to be the crucial trigger. There is no proven medical cure for the disease, and symptomatic treatment options are limited. Anecdotal reports have shown partial or complete resolution of NSF following successful renal transplantation early in the course of NSF. In this report, we describe alleviation of NSF symptoms in two women following successful renal transplantation more than 3 years after onset of NSF. Dial. Transplant.
{"title":"Nephrogenic systemic fibrosis symptoms alleviated by renal transplantation","authors":"Nannie Bangsgaard MD, Jesper Melchior Hansen MD, PhD, DMSc, Peter Marckmann MD, DMSc, Lone Skov MD, PhD, DMSc","doi":"10.1002/dat.20507","DOIUrl":"10.1002/dat.20507","url":null,"abstract":"<p>Nephrogenic systemic fibrosis (NSF) is a rare, serious, and life-threatening disease of patients with severe renal impairment. Gadolinium-containing contrast agents have been shown to be the crucial trigger. There is no proven medical cure for the disease, and symptomatic treatment options are limited. Anecdotal reports have shown partial or complete resolution of NSF following successful renal transplantation early in the course of NSF. In this report, we describe alleviation of NSF symptoms in two women following successful renal transplantation more than 3 years after onset of NSF. Dial. Transplant.</p>","PeriodicalId":51012,"journal":{"name":"Dialysis & Transplantation","volume":"40 2","pages":"86-87"},"PeriodicalIF":0.0,"publicationDate":"2011-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/dat.20507","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"51496772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A new injectable antibiotic, ceftaroline fosamil (Teflaro), has been approved by the United States (U.S.) Food and Drug Administration (FDA) to treat adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).1 A dosage adjustment is necessary in patients with moderately impaired renal function (CrCl 30 mL/min to < 50 mL/min) or severely impaired renal function (CrCl < 30 mL/min).2 The most common side effects in trials were diarrhea, nausea, and rash.
Daptomycin for injection (Cubicin) was recently FDA-approved as a oncedaily two-minute intravenous (IV) injection.3 Previously it was approved as a 30-minute infusion for treating MRSA-complicated skin infections and bacteremia.
Atrasentan (Xinlay), a highly selective endothelin-A receptor antagonist (SERA), which antagonizes the effect of endothelin-l (ET-l), led to reductions in residual albuminuria in diabetic nephropathy patients when added to angiotensin receptor blocker or angiotensin-converting-enzyme inhibitor therapy.4 The middle atrasentan dose reduced the urine albumin-to-creatinine (UACR) ratio by 42% compared with reductions of 34% and 21% with the highest and lowest doses, respectively.5 Half the patients who received the middle dose also realized a >40% reduction in UACR from baseline versus 17% for placebo-treated patients.
Bardoxolone, a first-in-class antioxidant inflammation modulator for treating chronic kidney disease (CKD), was shown in mid-stage clinical trials to significantly improve renal function in patients with CKD and type 2 diabetes mellitus (T2DM).6 Phase 3 clinical trials are expected to be started soon.
A complete response letter related to the potential approval of exenatide extended-release for injectable suspension (Bydureon), was received by its manufacturer on October 19, 2010.7 The FDA has requested that exenatide extended-release undergo a comprehensive QT study at higher dose exposure levels to determine the effect of the drug on patient heart rate.8 The dose to be studied will be supratherapeutic. Additional efficacy data from studies already conducted were also requested by the FDA. It is anticipated that the response to the FDA letter will be completed by the end of 2011. It is intended for once-weekly injection.
Ferric citrate (Zerenex) is currently in Phase 3 clinical trials to treat hyperphosphatemia in end-stage renal disease (ESRD) patients on dialysis.9 The strength of this oral formulation is 1 gram. Patients who received 6 grams of ferric citrate daily had a decrease in serum phosphorous levels of 25% after 28 days, those who took 8 grams had a 29% drop in 28 days, and those who took 1 gram daily showed no serum phosphorous reduction. A 58-week study is ongoing
{"title":"Rx Report†","authors":"","doi":"10.1002/dat.20540","DOIUrl":"https://doi.org/10.1002/dat.20540","url":null,"abstract":"<p>A new injectable antibiotic, ceftaroline fosamil (Teflaro), has been approved by the United States (U.S.) Food and Drug Administration (FDA) to treat adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant <i>Staphylococcus aureus</i> (MRSA).<span>1</span> A dosage adjustment is necessary in patients with moderately impaired renal function (CrCl 30 mL/min to < 50 mL/min) or severely impaired renal function (CrCl < 30 mL/min).<span>2</span> The most common side effects in trials were diarrhea, nausea, and rash.</p><p>Daptomycin for injection (Cubicin) was recently FDA-approved as a oncedaily two-minute intravenous (IV) injection.<span>3</span> Previously it was approved as a 30-minute infusion for treating MRSA-complicated skin infections and bacteremia.</p><p>Atrasentan (Xinlay), a highly selective endothelin-A receptor antagonist (SERA), which antagonizes the effect of endothelin-l (ET-l), led to reductions in residual albuminuria in diabetic nephropathy patients when added to angiotensin receptor blocker or angiotensin-converting-enzyme inhibitor therapy.<span>4</span> The middle atrasentan dose reduced the urine albumin-to-creatinine (UACR) ratio by 42% compared with reductions of 34% and 21% with the highest and lowest doses, respectively.<span>5</span> Half the patients who received the middle dose also realized a >40% reduction in UACR from baseline versus 17% for placebo-treated patients.</p><p>Bardoxolone, a first-in-class antioxidant inflammation modulator for treating chronic kidney disease (CKD), was shown in mid-stage clinical trials to significantly improve renal function in patients with CKD and type 2 diabetes mellitus (T2DM).<span>6</span> Phase 3 clinical trials are expected to be started soon.</p><p>A complete response letter related to the potential approval of exenatide extended-release for injectable suspension (Bydureon), was received by its manufacturer on October 19, 2010.<span>7</span> The FDA has requested that exenatide extended-release undergo a comprehensive QT study at higher dose exposure levels to determine the effect of the drug on patient heart rate.<span>8</span> The dose to be studied will be supratherapeutic. Additional efficacy data from studies already conducted were also requested by the FDA. It is anticipated that the response to the FDA letter will be completed by the end of 2011. It is intended for once-weekly injection.</p><p>Ferric citrate (Zerenex) is currently in Phase 3 clinical trials to treat hyperphosphatemia in end-stage renal disease (ESRD) patients on dialysis.<span>9</span> The strength of this oral formulation is 1 gram. Patients who received 6 grams of ferric citrate daily had a decrease in serum phosphorous levels of 25% after 28 days, those who took 8 grams had a 29% drop in 28 days, and those who took 1 gram daily showed no serum phosphorous reduction. A 58-week study is ongoing","PeriodicalId":51012,"journal":{"name":"Dialysis & Transplantation","volume":"40 2","pages":"89-90"},"PeriodicalIF":0.0,"publicationDate":"2011-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1002/dat.20540","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"137685846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}