Background. The evidence base regarding the safety of intravenous (IV) iron therapy in patients with chronic kidney disease (CKD) is incomplete and largely based on small studies of relatively short duration.
Methods. FIND-CKD (ClinicalTrials.gov number NCT00994318) was a 1-year, open-label, multicenter, prospective study of patients with nondialysis-dependent CKD, anemia and iron deficiency randomized (1:1:2) to IV ferric carboxymaltose (FCM), targeting higher (400–600 µg/L) or lower (100–200 µg/L) ferritin, or oral iron. A post hoc analysis of adverse event rates per 100 patient-years was performed to assess the safety of FCM versus oral iron over an extended period.
Results. The safety population included 616 patients. The incidence of one or more adverse events was 91.0, 100.0 and 105.0 per 100 patient-years in the high ferritin FCM, low ferritin FCM and oral iron groups, respectively. The incidence of adverse events with a suspected relation to study drug was 15.9, 17.8 and 36.7 per 100 patient-years in the three groups; for serious adverse events, the incidence was 28.2, 27.9 and 24.3 per 100 patient-years. The incidence of cardiac disorders and infections was similar between groups. At least one ferritin level ≥800 µg/L occurred in 26.6% of high ferritin FCM patients, with no associated increase in adverse events. No patient with ferritin ≥800 µg/L discontinued the study drug due to adverse events. Estimated glomerular filtration rate remained the stable in all groups.
Conclusions. These results further support the conclusion that correction of iron deficiency anemia with IV FCM is safe in patients with nondialysis-dependent CKD.
Background
Dent's disease type 1 (DD1) is a rare X-linked nephropathy caused by CLCN5 mutations, characterized by proximal tubule dysfunction, including low-molecular-weight proteinuria (LMWP), hypercalciuria, nephrolithiasis-nephrocalcinosis, progressive chronic kidney disease (CKD) and kidney failure (KF). Current management is symptomatic and does not prevent disease progression. Here we describe the contemporary DD1 picture across Europe to highlight its unmet needs.
Methods
A physician-based anonymous international e-survey supported by several European Nephrology Networks/Societies was conducted. Questions focused on DD1 clinical features, diagnostic procedure and mutation spectrum.
Results
Two-hundred seven DD1 male patients were reported, being clinical data available for 163 with confirmed CLCN5 mutations. Proteinuria was the most common leading manifestation (49.1%). During follow-up, all patients showed LMWP, 66.4% nephrocalcinosis, 44.4% hypercalciuria and 26.4% nephrolithiasis. After 5.5 years, ∼50% of patients presented renal dysfunction, 20.7% developed CKD ≥ 3, and 11.1% KF. At last visit, hypercalciuria was more frequent in pediatric patients than in adults (73.4% vs. 19.0%). Conversely, nephrolithiasis, nephrocalcinosis and renal dysfunction were more prominent in adults. Furthermore, CKD progressed with age. Despite no clear phenotype/genotype correlation was observed, decreased glomerular filtration rate was more frequent in subjects with CLCN5 mutations affecting the pore or CBS domains compared to those with early-stop mutations.
Conclusions
Results from this large DD1 cohort confirm previous findings and provide new insights regarding age and genotype impact on CKD progression. Our data strongly support that DD1 should be considered in male patients with CKD, nephrocalcinosis/hypercalciuria and non-nephrotic proteinuria and provide additional support for new research opportunities.
Abstract:Visceral leishmaniasis (VL) is endemic in Mediterranean countries. Among immunosuppressed patients, the disease can manifest with atypical clinical features. An unusual clinical manifestation of the disease is fever of unknown origin (FUO). F-18 fluorodeoxyglucose positron emission tomography-computed tomography (F-18 FDG PET) may be useful for detecting inflammatory foci by observing increased metabolism in activated granulocytes and macrophages. We report two cases of PET/CT total body imaging showing a diffuse increase of reticuloendothelial metabolic activity in the spleen and vertebral bodies in two patients diagnosed with VL by direct detection of amastigotes in bone marrow biopsy.
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