ABSTRACT
Abstract Introduction: The mineral bone disorder, particularly secondary hyperparathyroidism, in chronic kidney disease (CKD) has a systemic impact affecting not only bone metabolism. Therefore its correction is important to prevent cardiovascular, inflammatory and immune diseases. Objective To assess the effectiveness and safety of intravenous paricalcitol administered over a 6 month period for the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing conventional hemodialysis, with close follow-up of treatment response. Methods: A phase 4 clinical trial was performed comparing clinical and laboratory data before and after 6 months of treatment. SHPT patients undergoing hemodialysis who were naïve to vitamin D metabolites or had failed to current therapy were included. Clinical and laboratory characteristics were analyzed. Efficacy analyses were based on intact parathyroid hormone (iPTH) levels and were performed using data from patients who completed 6 months of treatment. Results: Nineteen of the 26 patients enrolled completed 6 months of treatment. All patients exhibited reduced baseline iPTH levels (mean reduction, 371.8 pg/mL; 95% CI, 273.3-470.2 pg/mL]; 17 patients (89.5%) had reductions exceeding 30%. Twelve patients (63%) achieved therapeutic success (defined as iPTH serum levels 150-300 pg/mL), with a median time of 2 months from the beginning of treatment. All reported episodes of hypercalcemia (n = 2) and hyperphosphatemia (n = 34) were asymptomatic. No major therapy-related serious AEs were reported. Conclusion: Paricalcitol was safely administered and was associated with significant decreases in iPTH levels over the study period.
Resumo Introdução: A doença metabólica óssea, em particular o hiperparatireoidismo secundário, na doença renal crônica (DRC) tem um impacto sistêmico que afeta nem só o metabolismo ósseo. Por tanto, sua correção é importante para prevenir as doenças do sistema imunitário, inflamatório e cardiovascular. Objetivo: Avaliar a eficácia e a segurança do paricalcitol intravenoso administrado durante um período de 6 meses no tratamento do hiperparatireoidismo secundário (SHPT) em pacientes submetidos a hemodiálise convencional, com acompanhamento de perto da resposta do tratamento. Métodos: Realizou-se um ensaio clínico de fase 4 que comparava os dados clínicos com os dados do laboratório antes e depois dos 6 meses de tratamento. Incluíram-se os pacientes SHPT em hemodiálise sem experiência com os metabólitos da vitamina D ou que fracassaram com a terapia em uso. Analisaram-se as características clínicas e de laboratório. As análises de eficácia se basearam nos níveis do hormônio da paratireóide intacto (iPTH) e foram realizadas usando dados dos pacientes que completaram os 6 meses de tratamento. Resultados: Dezenove dos 26 pacientes registrados completaram os 6 meses de tratamento. Todos os pacientes mostraram níveis de referência iPTH reduzidos (redução média, 371,8 pg/mL; 95% CI, 273,3-470.2 pg/mL]; 17 pacientes (89,5%) tiveram reduções superiores a 30%. Doze pacientes (63%) conseguiram o sucesso terapêutico (definido como níveis de soros iPTH de 150-300 pg/mL), com um tempo médio de 2 meses a partir do início do tratamento. Todos os episódios de hipercalcemia (n = 2) e de hiperfosfatemia (n = 34) reportados foram assintomáticos. Não se informaram AEs graves importantes relacionados à terapia. Conclusão: O paricalcitol foi administrado de forma segura e se associou às reduções significativas nos níveis de iPTH durante o período do estudo.
Subject(s)
Humans , Male , Female , Middle Aged , Aged , Ergocalciferols/administration & dosage , Renal Dialysis , Hyperparathyroidism, Secondary/drug therapy , Time Factors , Ergocalciferols/adverse effects , Prospective Studies , Treatment Outcome , Injections, IntravenousABSTRACT
Clq nephropathy (Clq N) is an infrequent disease and only about 100 cases have been reponed. It is defined by a pattern of immunofluorescense (IF) with dominant or co-dominant complement Clq with electrondense deposits in the mesangium, without clinical or serological features of Lupus Nephritis. The most common histopathological findings of ClqN are focal segmental glomerulosclerosis and Minimal Change Disease. We repon a 17 year-old male patient with an isolated selective proteinuría found in a routine study. He had normal renal function and uriñe culture was negative. Serum lipids, liver enzymes an complement were all normal. Serum antinuclear and anti-DNA antibodies, antineutrophil cytoplasmic antibodies (ANCA), HIV, Hepatitis B and C serology, were negative. Renal and abdominal ultrasonography was normal. The histopathological study revealed segmental glomerular sderosis, modérate increase of mesangial matrix, Bowmann capsule adhesions and fucsinophil deposits in mesangium. The IF was positive (dominant) for Clq (+++) and IgA, IgG, IgM, C3++, all of them with a granular mesangial distribution. Ultrastructural findings were pedicelar effacement and paramesangial electrondense deposits. Tubular reticular inclusions (TRI) were not found. Remission of proteinuría was reached after 18 months of treatment with enalapril and losartan. The patient remains with normal renal function. Clinical findings, negative serology for Lupus, light microscopy IFwith dominant positivity for Clq, absence of TRI and paramesangial electrondense deposits in electron microscopy lead us to the diagnosis of ClqN. A poor response to steroid therapy was described in ClqN. Thus it was worthwhile to differentiate it from lupus nephritis, that is responsive to steroids.