Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

Effect of operating surgeon on outcome of arteriovenous fistula formation.

OBJECTIVE To study whether surgical trainees can perform arteriovenous fistula (AVF) surgery to a standard comparable to consultants. PATIENTS AND METHODS Retrospective study of all vascular access surgery over a three year period at a single centre. The operating surgeon was identified from theatre log books and categorised by grade. Fistula patency was used as the primary outcome measure and was determined from patients' case-notes and from a prospectively collected electronic record of dialysis sessions. Patency was defined as "used for dialysis" if the AVF was used for dialysis for at least 6 consecutive sessions. RESULTS One hundred and eighty six cases were used for analysis. In 60 cases (32%) the operating surgeon was the consultant, in 53 cases (29%) a trainee was supervised by a consultant, in 56 cases (30%) a trainee performed the operation independently and in 17 cases (9%) the grade of the operating surgeon could not be established. Primary and primary assisted patency rates by operating surgeon did not differ significantly (P-values 0.25 and 0.16 respectively). Age of the patient was the only predictor of patency failure in a multivariate model. Grade of operating surgeon (logrank test chi(2)=3.1, p=0.38) and type of fistula (logrank test chi(2)=2.3, p=0.52) were not significantly related to the primary survival of the fistula. CONCLUSIONS This study showed no significant differences in AVF patency rates between trainee and consultant surgeons. Allocation of appropriate cases can result in trainees obtaining similar outcomes as consultants, demonstrating that dialysis access surgery can provide good training opportunities for junior doctors without detriment to patient care

Survival in dialysis patients is different between patients with diabetes as primary renal disease and patients with diabetes as a co-morbid condition.

A previous study in Dutch dialysis patients showed no survival difference between patients with diabetes as primary renal disease and those with diabetes as a co-morbid condition. As this was not in line with our hypothesis, we aimed to verify these results in a larger international cohort of dialysis patients. For the present prospective study, we used data from the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Registry. Incident dialysis patients with data on co-morbidities (n = 15,419) were monitored until kidney transplantation, death or end of the study period (5 years). Cox regression was performed to compare survival for patients with diabetes as primary renal disease, patients with diabetes as a co-morbid condition and non-diabetic patients. Of the study population, 3,624 patients (24%) had diabetes as primary renal disease and 1,193 (11%) had diabetes as a co-morbid condition whereas the majority had no diabetes (n = 10,602). During follow-up, 7,584 (49%) patients died. In both groups of diabetic patients mortality was higher compared with the non-diabetic patients. Mortality was higher in patients with diabetes as primary renal disease than in patients with diabetes as a co-morbid condition, adjusted for age, sex, country and malignancy (HR 1.20, 95% CI 1.10, 1.30). An analysis stratified by dialysis modality yielded similar results. Overall mortality was significantly higher in patients with diabetes as primary renal disease compared with those with diabetes as a co-morbid condition. This suggests that survival in diabetic dialysis patients is affected by the extent to which diabetes has induced organ damag

International comparison of trends in patients commencing renal replacement therapy by primary renal disease

AimTo examine international time trends in the incidence of renal replacement therapy (RRT) for end�stage renal disease (ESRD) by primary renal disease (PRD).MethodsRenal registries reporting on patients starting RRT per million population for ESRD by PRD from 2005 to 2014, were identified by internet search and literature review. The average annual percentage change (AAPC) with a 95% confidence interval (CI) of the time trends was computed using Joinpoint regression.ResultsThere was a significant decrease in the incidence of RRT for ESRD due to diabetes mellitus (DM) in Europe (AAPC=�0.9; 95%CI�1.3;�0.5) and to hypertension/renal vascular disease (HT/RVD) in Australia (AAPC=�1.8; 95%CI�3.3;�0.3), Canada (AAPC=�2.9; 95%CI�4.4;�1.5) and Europe (AAPC=�1.1; 95%CI�2.1;�0.0). A decrease or stabilization was observed for glomerulonephritis in all regions and for autosomal dominant polycystic kidney disease (ADPKD) in all regions except for Malaysia and the Republic of Korea. An increase of 5.2% to 16.3% was observed for DM, HT/RVD and ADPKD in Malaysia and the Republic of Korea.ConclusionLarge international differences exist in the trends in incidence of RRT by primary renal disease. Mapping of these international trends is the first step in defining the causes and successful preventative measures of CKD