Lectin-Like Oxidized Low-Density Lipoprotein Receptor 1 Inhibition in Type 2 Diabetes: Phase 1 Results.

Background Blockade of the lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) is a potentially attractive mechanism for lowering inflammatory and lipid risk in patients with atherosclerosis. This study aims to assess the safety, tolerability, and target engagement of MEDI6570, a high-affinity monoclonal blocking antibody to LOX-1. Methods and Results This phase 1, first-in-human, placebo-controlled study (NCT03654313) randomized 88 patients with type 2 diabetes to receive single ascending doses (10, 30, 90, 250, or 500 mg) or multiple ascending doses (90, 150, or 250 mg once monthly for 3 months) of MEDI6570 or placebo.

Development and Validation of a Transfusion Risk Score for Patients Receiving Maintenance Hemodialysis.

Background: In patients on dialysis with anemia, avoiding red blood cell transfusions is preferable. We sought to develop and validate a novel transfusion prediction risk score for patients receiving maintenance hemodialysis.

Methods: This retrospective cohort study used United States Renal Data System data to create a model development cohort (patients who were point prevalent and on hemodialysis on November 1, 2012) and a validation cohort (patients who were point prevalent and on hemodialysis on August 1, 2013).

Inflammation and Erythropoiesis-Stimulating Agent Response in Hemodialysis Patients: A Self-matched Longitudinal Study of Anemia Management in the Dialysis Outcomes and Practice Patterns Study (DOPPS).

Rationale & Objective: Previous studies of inflammation and anemia management in hemodialysis (HD) patients may be biased due to patient differences. We used a self-matched longitudinal design to test whether new inflammation, defined as an acute increase in C-reactive protein (CRP) level, reduces hemoglobin response to erythropoiesis-stimulating agent (ESA) treatment.

Study Design: Self-matched longitudinal design.

Major adverse cardiovascular events in people with chronic kidney disease in relation to disease severity and diabetes status.

Diabetes plays an important role in the complex relationship between chronic kidney disease (CKD) and cardiovascular disease. This retrospective observational study compared the influence of estimated glomerular filtration rate (eGFR) and proteinuria on the risk of major adverse cardiovascular event (MACE; myocardial infarction or stroke) in CKD patients with and without diabetes. Data were from a linked database of UK electronic health records.

Epidemiology and health outcomes associated with hyperkalemia in a primary care setting in England.

Background: Real-world incidence, clinical consequences, and healthcare resource utilization (HRU) of hyperkalemia (HK) remain poorly characterized, particularly in patients with specific comorbidities.

Methods: Data from the Clinical Practice Research Datalink and Hospital Episode Statistics databases were analyzed to determine incidence of an index HK event, subsequent clinical outcomes, and HRU in the English population. Factors associated with index HK in a primary care setting were also identified for those with an index HK event during the study period (2009-2013) and matched controls.

Predialysis anemia management and outcomes following dialysis initiation: A retrospective cohort analysis.

Whether and how anemia treatment with erythropoiesis stimulating agents (ESAs) before hemodialysis initiation may be associated with lower mortality after dialysis initiation is unknown. We compared all-cause and cardiovascular mortality in two groups of patients who experienced distinct anemia treatment patterns with ESAs before and after hemodialysis initiation. This retrospective cohort analysis included patients initiating hemodialysis April 1, 2012-June 30, 2013, identified from United States Renal Data System end-stage renal disease (ESRD) and pre-ESRD files.

The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial.

Background: Phosphate binders are the cornerstone of hyperphosphatemia management in dialysis patients. Ferric citrate is an iron-based oral phosphate binder that effectively lowers serum phosphorus levels.

Study Design: 52-week, open-label, phase 3, randomized, controlled trial for safety-profile assessment.

Ferric citrate spans mineral metabolism and anemia domains in ESRD: a review of efficacy and safety data.

Ferric citrate (Zerenex™, Keryx Biopharmaceuticals, Inc.), a phosphate binder drug candidate, recently completed a Phase III program confirming efficacy and demonstrating safety when used to treat hyperphosphatemia in patients with end-stage renal disease. Results of these trials demonstrate that ferric citrate effectively controls serum phosphorus and is well tolerated.

The safety and tolerability of ferric citrate as a phosphate binder in dialysis patients.

Background: A phase II open-label study was conducted in hemodialysis patients evaluating the short-term safety, tolerability, and iron absorption with ferric citrate when used as a phosphate binder.

Methods: Enrollment occurred in two periods. Period 1 recruited patients taking 6-15 pills/day of binder with phosphorus of ≥2.

At-home short daily hemodialysis improves the long-term health-related quality of life.

Patients with chronic kidney disease treated by in-center conventional hemodialysis (3 times per week) have significant impairments in health-related quality of life measures, which have been associated with increased morbidity and mortality. FREEDOM is an ongoing prospective cohort study measuring the potential benefits of at-home short daily (6 times per week) hemodialysis. In this interim report we examine the long-term effect of short daily hemodialysis on health-related quality of life, as measured by the SF-36 health survey.

Life-Threatening Hypocalcemia following Subtotal Parathyroidectomy in a Patient with Renal Failure and Previous Roux-en-Y Gastric Bypass Surgery.

Background. Roux-en-Y gastric bypass (RYGB) can result in calcium and vitamin D deficiency. Parathyroid surgery carries the risk of immediate and long-term hypocalcemia.

Laparoscopy in the early diagnosis and management of sclerosing encapsulating peritonitis.

Sclerosing encapsulating peritonitis (SEP) is a rare and dreaded complication that can occur in patients undergoing peritoneal dialysis (PD). Although risk factors have been identified, the diagnosis is difficult and is usually made late in the disease after extensive fibrosis of the peritoneal membrane has occurred, at which point therapy is often fruitless. The high mortality rate of SEP is due to complications resulting from recurrent bowel obstruction, malnutrition, and sepsis.

A randomized trial of a 6-week course of celecoxib on proteinuria in diabetic kidney disease.

Background: Preclinical data suggest that cyclooxygenase 2 inhibitors decrease proteinuria and preserve glomerular structure in animal models of diabetic nephropathy. The objective of this study is to compare the efficacy and safety of celecoxib with placebo for decreasing proteinuria in patients with diabetic nephropathy.

Study Design: Placebo-controlled double-blinded crossover design.

Clinical implications of proteinuria.

Proteinuria has long been considered a marker for renal disease. New observations are suggesting that proteinuria is also a risk factor for other outcomes as well, such as cardiac events and stroke. This article will review a recommended strategy for proteinuria detection and the associations of proteinuria with the progression of renal disease and cardiovascular disease.

Radioactive 131I use in end-stage renal disease: nightmare or nuisance?

Patients with end-stage renal disease (ESRD) are at risk of prolonged radiation exposure during therapy with radioactive iodine (131I) because it is normally renally excreted. However, 131I is dialyzable and exposure can be monitored with a standard Geiger counter during dialysis. We present two cases of thyroid carcinoma in patients with ESRD who were treated successfully with 131I while continuing chronic hemodialysis (HD).