Challenges of Conducting Clinical Trials during the SARS-CoV-2 Pandemic: The ASCEND Global Program Experience.

The coronavirus disease 2019 pandemic has had an unprecedented effect on health and health care and posed challenges to the conduct of clinical trials.Targeted mitigating strategies, on the basis of early and continued data collection from site surveys, limited disruption to the ASCEND trials.Flexibly allowing hemoglobin assessment at local laboratories to inform randomized treatment dosing was key to limiting the discontinuation of treatment.

Clinical and Economic Outcomes of Erythropoiesis-Stimulating Agent Hyporesponsiveness in the Post-Bundling Era.

Rationale & Objective: Since the change in erythropoiesis-stimulating agent (ESA) labeling and bundling of dialysis services in the United States, few studies have addressed the clinical importance of ESA hyporesponsiveness and none have considered health care resource use in this population. We aimed to further explore ESA hyporesponsiveness and its consequences.

Study Design: Retrospective observational cohort study.

Cardiovascular Event Rates Among Hemodialysis Patients Across Geographical Regions-A Snapshot From The Dialysis Outcomes and Practice Patterns Study (DOPPS).

Introduction: Cardiovascular (CV) morbidity and mortality are excessively high among hemodialysis (HD) patients. Anemia is a common complication of chronic kidney disease (CKD) and a known risk factor for CV events. To understand the impact of the recent regulatory and guideline changes in anemia management, we examined regional CV event rates in high-risk and erythropoiesis-stimulating agent (ESA)-hyporesponsive HD patients.

Anemia and mortality in patients with nondialysis-dependent chronic kidney disease.

Background: A combination of safety concerns and labeling changes impacted use of erythropoiesis-stimulating agents (ESAs) in renal anemia. Data regarding contemporary utilization in pre-dialysis chronic kidney disease (CKD) are lacking.

Methods: Electronic healthcare records and medical claims data of pre-dialysis CKD patients were aggregated from a large US managed care provider (2011-13).

The occurrence of increased intraperitoneal volume events in automated peritoneal dialysis in the US: role of programming, patient/user actions and ultrafiltration.

Unlabelled: BACKGROUND, OBJECTIVES AND METHODS: Increased intraperitoneal volume (IIPV) can occur during automated peritoneal dialysis (APD). The contribution of factors such as cycler programming and patient/user actions to IIPV has not been previously explored. The relationship between IIPV and cycler programming, patient/user actions, and ultrafiltration over a two-year period was investigated using US data from Baxter cyclers.

A mathematical model to optimize the drain phase in gravity-based peritoneal dialysis systems.

Use of patient-specific drain-phase parameters has previously been suggested to improve peritoneal dialysis (PD) adequacy. Improving management of the drain period may also help to minimize intraperitoneal volume (IPV). A typical gravity-based drain profile consists of a relatively constant initial fast-flow period, followed by a transition period and a decaying slow-flow period.

Relationship between drain volume/fill volume ratio and clinical outcomes associated with overfill complaints in peritoneal dialysis patients.

Background: To better understand the spectrum of overfill reports and their corresponding clinical severity and etiology, we conducted a review of overfill reports from the Manufacturer and User Facility Device Experience (MAUDE) database, which is within the Food and Drug Administration (FDA) Web site (www.fda.gov).

The costs and benefits of automatic estimated glomerular filtration rate reporting.

Background And Objectives: The prevalence of chronic kidney disease (CKD) has increased over the past two decades. The sensitivity of serum creatinine (sCr) to identify CKD is low. As a result, many healthcare centers report estimated GFR (eGFR) with routine blood work.

Association of donor inflammation- and apoptosis-related genotypes and delayed allograft function after kidney transplantation.

Background: Delayed renal allograft survival (delayed graft function [DGF]) after deceased donor kidney transplantation is associated with an increased risk of allograft loss. Inflammatory response and apoptosis are associated with increased risk of DGF.

Study Design: Cross-sectional study.

Combination embolization and radiofrequency ablation therapy for renal cell carcinoma in the setting of coexisting arterial disease.

The present report describes two cases of T1b (>4 cm) renal cell carcinoma (RCC) treated with superselective embolization and radiofrequency ablation in the setting of renal artery stenosis and abdominal aortic aneurysm, respectively. In the first case, a solitary functioning kidney was treated with stent placement immediately before RCC embolization. In the second case, a brachial artery approach was used for RCC embolization after a failed femoral approach secondary to an abdominal aortic aneurysm.

Nephrotic syndrome after hematopoietic cell transplantation: do glomerular lesions represent renal graft-versus-host disease?

Glomerular disease associated with nephrotic syndrome has rarely been recognized as a distinct complication of allogeneic hematopoietic cell transplantation. Case reports in the English and Japanese literature since 1988 have described variable glomerular histology, comprising mainly membranous glomerulonephritis (MGN) in almost two thirds and minimal change disease (MCD) in nearly one quarter of patients. Review of the literature reveals a close temporal relationship between the development of nephrotic syndrome shortly after cessation of immunosuppression and the diagnosis of chronic graft-versus-host disease (GVHD).

Administration of parenteral iron and mortality among hemodialysis patients.

The objective of this study was to evaluate whether the apparent relationship demonstrated in prior studies between iron dosing and mortality in hemodialysis (HD) patients was confounded by incomplete representation of iron dosing and morbidity over time. A cohort study was conducted among 32,566 patients who received at least 1 yr of HD at the Fresenius Medical Corporation dialysis centers during 1996 to 1997. The outcome measure was all-cause mortality through mid-1998.