A5035767298- Erythropoietin and Anemia Treatment
- Dialysis and Renal Disease Management
- Hemoglobinopathies and Related Disorders
- Iron Metabolism and Disorders
- Chronic Kidney Disease and Diabetes
- Renal Transplantation Outcomes and Treatments
- Pharmacological Effects and Toxicity Studies
- Blood transfusion and management
- Organ Donation and Transplantation
- Organ Transplantation Techniques and Outcomes
- Blood Pressure and Hypertension Studies
- Central Venous Catheters and Hemodialysis
- Healthcare Policy and Management
- Renal and Vascular Pathologies
- Health Systems, Economic Evaluations, Quality of Life
- Renal Diseases and Glomerulopathies
- Vascular Procedures and Complications
- Transplantation: Methods and Outcomes
- Hemodynamic Monitoring and Therapy
- SARS-CoV-2 and COVID-19 Research
- Luminescence Properties of Advanced Materials
- Urological Disorders and Treatments
- Neurological Complications and Syndromes
- Pediatric Urology and Nephrology Studies
- Cardiac, Anesthesia and Surgical Outcomes
Wayne State University
2020-2022
Ascension
2022
St. John Hospital & Medical Center
2004-2020
University of Florida
2020
Columbus Oncology and Hematology Associates
2020
Villa Pineta Hospital
2018
DaVita Clinical Research (United States)
2009-2015
St. Clair College
2013
Detroit Medical Center
2000
Henry Ford Hospital
1988
Roxadustat (FG-4592), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis, regulates iron metabolism, and reduces hepcidin, was evaluated in this phase 2b study for safety, efficacy, optimal dose, dose frequency patients with nondialysis CKD.The 145 CKD hemoglobin ≤10.5 g/dl were randomized into one of six cohorts approximately 24 each varying roxadustat starting doses (tiered weight fixed amounts) frequencies (two three times weekly) followed by...
Background.Roxadustat (FG-4592) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis.This Phase 2a study tested efficacy (Hb response) and safety of roxadustat in anemic nondialysis-dependent chronic kidney disease (NDD-CKD) subjects.Methods.NDD-CKD subjects with hemoglobin (Hb) ≤11.0 g/ dL were sequentially enrolled into four dose cohorts randomized to or placebo two times weekly (BIW) three (TIW) for 4 weeks, approximate roxadustat: ratio...
Roxadustat (FG-4592) is an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin.Phase 2, randomized (3:1), open-label, active-comparator, safety efficacy study.Patients with stable end-stage renal disease treated hemodialysis who previously had hemoglobin (Hb) levels maintained epoetin alfa.Part 1: 6-week dose-ranging study in 54 individuals of thrice-weekly...
Abstract Background We evaluated the efficacy and safety of roxadustat versus epoetin alfa for treatment chronic kidney disease-related anemia in patients new to dialysis. Methods HIMALAYAS was a Phase 3, open-label, alfa-controlled trial. Eligible adults were incident hemodialysis/peritoneal dialysis 2 weeks ≤4 months prior randomization had mean hemoglobin (Hb) ≤10.0 g/dL. Primary endpoints Hb (g/dL) change from baseline averaged over Weeks 28–52 regardless rescue therapy [non-inferiority...
Intravenous iron is a key component of anemia management for chronic kidney disease (CKD). Ferumoxytol unique intravenous product that can be administered as rapid injection in doses up to 510 mg.This was randomized, open-label, controlled, multicenter Phase 3 trial evaluate the safety and efficacy ferumoxytol compared with oral iron. Anemic patients CKD stage 5D on hemodialysis stable erythropoiesis-stimulating agent regimen received either two injections mg within 7 d (n = 114) or 200...
Peginesatide is a peptide-based erythropoiesis-stimulating agent (ESA) that may have therapeutic potential for anemia in patients with advanced chronic kidney disease. We evaluated the safety and efficacy of peginesatide, as compared another ESA, darbepoetin, 983 such who were not undergoing dialysis.In two randomized, controlled, open-label studies (PEARL 1 2), received peginesatide once month, at starting dose 0.025 mg or 0.04 per kilogram body weight, darbepoetin every 2 weeks, 0.75 μg...
Peginesatide, a synthetic peptide-based erythropoiesis-stimulating agent (ESA), is potential therapy for anemia in patients with advanced chronic kidney disease.We conducted two randomized, controlled, open-label studies (EMERALD 1 and EMERALD 2) involving undergoing hemodialysis. Cardiovascular safety was evaluated by analysis of an adjudicated composite end point--death from any cause, stroke, myocardial infarction, or serious adverse events congestive heart failure, unstable angina,...
Background and objectives We evaluated the efficacy cardiovascular safety of roxadustat versus placebo by analyzing data pooled from three phase 3 studies in patients with non–dialysis-dependent CKD CKD-related anemia. Design, setting, participants, & measurements In 3, double-blind evaluating treatment anemia not requiring dialysis, primary end point was mean change baseline hemoglobin averaged over weeks 28–52, regardless rescue therapy. The a composite measure major adverse events...
This study examined the efficacy of C.E.R.A., a continuous erythropoietin receptor activator, for correcting anemia in patients who had chronic kidney disease (CKD) and were not on dialysis.In this open-label, randomized, parallel-group, Phase III study, 324 adult with CKD dialysis nor receiving treatment erythropoiesis-stimulating agents (ESAs) randomly assigned (1:1) to receive subcutaneous C.E.R.A. once every 2 wk or darbepoetin alfa weekly during an 18-wk correction period 10-wk...
THE pediatrician, general practitioner and public-health officer are concerned with early, safe, effective protection against diseases that can be prevented by the use of vaccines. The earliest time adequate active immunization accomplished in infants is very difficult to determine, fact not finally decided for any immunizing agents commonly used infancy,1 2 3 4 5 although basic processes involved immunology being pursued. Previous studies6,7 showed children at three weeks age effectively...
Components of grapefruit juice have been shown to inhibit CYP3A4 activity, the enzyme involved in cyclosporine metabolism. Eleven medically stable patients (seven males, four females) receiving following kidney transplantation were instructed take their usual dose with water for 1 week (Phase 1), (8 ounces) 2) and again 3). Trough blood samples obtained at end each phase measurement concentration using a specific monoclonal whole radioimmunoassay. Cyclosporine trough concentrations averaged...
To determine whether extended epoetin alfa dosing schedules of up to once every four weeks are as effective weekly in maintaining hemoglobin (Hb) levels patients with anemia chronic kidney disease (CKD).This randomized, open-label trial enrolled CKD not on dialysis. Patients were required have a stable Hb level (> or = 11.0 g/dl) and been previously receiving for two more months. randomized one subcutaneously administered regimens: 10,000 units (U) (QW), 20,000 U (Q2W), 30,000 three (Q3W)...
Objectives: To evaluate the relationship between hemoglobin (Hb) level and quality of life (QOL) in anemic patients with non-dialysis chronic kidney disease receiving epoetin alfa.Patients methods: A post-hoc analysis using data from a multicenter, open-label, prospective study alfa for anemia not on dialysis was conducted. The Hb QOL analyzed correlation longitudinal analyses, latter adjusting sample selection bias. Linear Analog Scale Assessment (LASA) Kidney Disease Questionnaire (KDQ)...
Thursday, March 8, 2007, is World Kidney Day! Day was proposed by the International Society of Nephrology and Federation Foundations in 2006 to broadcast a message about kidney diseases public, government health officials, general physicians, allied professionals, individuals, families. It launched on 9, 2006, will be fully inaugurated this year (http://www.worldkidneyday.org/).The that disease common, harmful treatable. In article, we focus chronic (CKD) as global public problem, urgent...
Background. No previous randomized controlled studies have been reported examining de novo , once every 4 weeks (Q4W) administration of erythropoiesis-stimulating agents in chronic kidney disease (CKD) patients. We report results from a multinational study that compared continuous erythropoietin receptor activator (C.E.R.A.) Q4W with darbepoetin alfa weekly (QW) or 2 (Q2W) for the correction anaemia non-dialysis CKD Methods. Patients were (1:1) to receive either 1.2 μg/kg C.E.R.A. QW/Q2W...
IntroductionErythropoiesis-stimulating agents are associated with increased cardiovascular risk when higher doses used toward hematocrit targets. Patients new to dialysis at for morbidity and mortality. Systematic evaluation of this population was predefined in the roxadustat clinical development program. Roxadustat is a hypoxia-inducible prolyl hydroxylase inhibitor.MethodsData were pooled from 3 phase 3, randomized, open-label, active-controlled trials. Eligible adults had kidney failure...
Anemia occurs in approximately 47% of patients with chronic kidney disease (CKD) not on dialysis. Recombinant human erythropoietin (r-HuEPO, epoetin alfa) has been proven safe and effective for anemia treatment CKD using a three times-weekly regimen. The current study was conducted to evaluate the clinical safety efficacy less frequent dosing regimen (once weekly) this population.This prospective, multicenter, open-label, non-randomized enrolled 1,557 adult anemic (hemoglobin (Hb) < or = 10...
Thursday, March 8, 2007, is World Kidney Day! Day was proposed by the International Society of Nephrology and Federation Foundations in 2006 to broadcast a message about kidney diseases public, government health officials, general physicians, allied
Abstract Roxadustat (FG‐4592), an oral hypoxia‐inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis, was evaluated in a phase 1b study patients with end‐stage renal disease anemia on hemodialysis. Seventeen patients, epoetin‐alfa maintenance therapy stable hemoglobin levels ≥10 g/dL, had discontinued day 3 and were enrolled this double‐blind placebo‐controlled study. Two cohorts randomized 3:1 (roxadustat: placebo). Patients received single doses of roxadustat (1 or 2...
HYPOFUNCTION of the adrencortical tissue in newborn infant presents a characteristic clinical syndrome. The manifestations that may result from temporary deficiency this gland have been suggested by several authors.1 2 3 4 5 6 7 8 No report has found pediatric literature such manifestations, however, with response on replacement therapy and confirmation diagnosis simple hypoplasia adrenocortical tissue. It is purpose paper to present case demonstrates clinically hypofunction which...
ALTHOUGH congenital dislocation is extremely rare, it the most frequent deformity of knee. In recent years occurrence and treatment this lesion have received considerable attention,1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 but to date an etiologic grouping has not been presented. It purpose paper formulate classification dislocations knee, review various cases reported determine incidence in relation hereditary tendencies, sex types...
The incidence of peritonitis ranges from 1 episode every 24 patient treatment months to 60 [Keane WF, et al. ISPD Guidelines/Recommendations. Adult peritoneal dialysis-related recommendations: 2000 update. Perit Dial Int 2000; 20:396-411.]. Gram-positive organisms account for over 80% continuous ambulatory dialysis (PD)-associated peritonitis. Recent fear vancomycin-resistant enterococci (VRE) has prompted suggestions limiting vancomycin use. Fifty-one episodes in 30 patients studied 2 years...