A randomized controlled trial of preemptive rituximab to prevent recurrent focal segmental glomerulosclerosis post-kidney transplant (PRI-VENT FSGS): protocol and study design.

BACKGROUND: Focal segmental glomerulosclerosis (FSGS) is a common cause of end-stage kidney disease requiring kidney transplantation and can recur in the allograft in 30-80% of recipients resulting in reduced graft survival. Plasmapheresis has shown efficacy in treating some cases of recurrent FSGS but isolated plasmapheresis has not demonstrated efficacy in preventing recurrent FSGS. Rituximab has had anecdotal success in preventing recurrence in a single center study but has not been studied in combination with plasmapheresis for preventing FSGS recurrence. METHODS: We are conducting a randomized, controlled, multicenter clinical trial of adult and pediatric kidney transplant recipients with primary FSGS to assess whether plasmapheresis in combination with rituximab prevents recurrent disease post-transplantation. DISCUSSION: Rituximab combined with plasmapheresis is a promising, novel therapy to prevent recurrent FSGS, a disease with limited therapeutic options and no consensus guidelines for prevention or treatment. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03763643, identifier NCT03763643

Cardiovascular disease in pediatric chronic dialysis patients

Cardiovascular disease in pediatric chronic dialysis patients.BackgroundLittle information is available regarding cardiac morbidity and mortality in children with end-stage renal disease. We sought to determine the incidence of cardiac morbidity and mortality in pediatric chronic dialysis patients.MethodsMedicare incident pediatric (0 to 19 years) dialysis patients from 1991 to 1996 were identified from the United States Renal Data System. Study endpoints included development of arrhythmia, valvular heart disease, cardiomyopathy, or cardiac arrest, all causes of death, and cardiac-related death. Statistical analyses were performed using the Poisson regression model and chi-square test.ResultsA total of 1454 children were eligible for inclusion, 452 (31.1%) of whom developed a cardiac-related event. Arrhythmia was the most common event (19.6%) compared with valvular disease (11.7%), cardiomyopathy (9.6%), and cardiac arrest (3%). Arrhythmia and valvular heart disease incidence were increased in 15- to 19-year-olds (P < 0.0001 for both), females (P = 0.004, P = 0.03) and blacks (P < 0.0001, P = 0.002). Cardiomyopathy incidence was increased in blacks (P = 0.001) and tended to be increased in females (P = 0.053). The adjusted annual cardiomyopathy rate during the first 3 years increased between 1991 and 1996 (P = 0.003). Death occurred in 107 patients, and 41 (38%) were cardiac deaths.ConclusionsCardiovascular disease is a significant cause of morbidity and mortality in pediatric chronic dialysis patients. Cardiomyopathy incidence is increasing. Black, female, and adolescent children have increased risk for cardiovascular disease

Albumin Excretion Rate in Normal Adolescents: Relation to Insulin Resistance and Cardiovascular Risk Factors and Comparisons to Type 1 Diabetes Mellitus Patients

Background and objectives: Although albumin excretion rates have been related to cardiovascular morbidity and mortality in both diabetic and nondiabetic adults, little is known about the relation between albuminuria and either cardiovascular risk factors or the insulin resistance syndrome in adolescents. A normal range for albumin excretion in adolescents was established, correlations between albumin excretion and cardiovascular risk factors were evaluated, and albumin excretion in normal adolescents was compared with that in type 1 diabetes mellitus adolescents