Evaluation of the safety and immunogenicity of subcutaneous HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in predialysis and dialysis patients
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AIM: To assess the safety and immunogenicity of subcutaneous (SC) HX575 (epoetin-α) in dialysis- and nondialysis-dependent adult patients with chronic kidney disease (CKD). METHODS: Open-label, single-arm, multicenter study in patients (n = 416) from Germany, Italy, Poland, Romania, Russia, Turkey, and Ukraine. RESULTS: Mean (standard deviation (SD)) age was 52.3 (15.8) years, all patients were Caucasian, and similar proportions were male/female. 250 patients (60.1%) were erythropoiesis-stimulating agent (ESA)-naïve, and 166 (39.9%) were receiving ESA maintenance therapy at study start; mean (SD) on-study treatment duration with HX575 was 43.4 (15.8) weeks and 45.3 (13.7) weeks, respectively. Binding antierythropoietin (EPO) antibodies were detected by radioimmunoprecipitation (RIP) assay in 7 patients (1.7%; incidence 0.019); 5 of these were ESA-naïve at study entry. No patient developed neutralizing antibodies as determined in a cell-based epoetin neutralizing assay. Of the 7 patients with a positive binding anti-EPO RIP assay, 4 tested negative at later time points while continuing HX575 treatment. Three patients had low titers of anti-EPO antibodies at the last study assessment. There were no clinical signs of immunogenicity or hypersensitivity. CONCLUSIONS: SC HX575 was effective for correcting and maintaining correction of anemia, and the mean weekly dose remained stable over time.
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Effect of the herbal combination Canephron N on diabetic nephropathy in patients with diabetes mellitus: results of a comparative cohort study.

OBJECTIVES: Diabetic nephropathy (DN) is a serious and common complication of diabetes mellitus leading to end-stage renal disease in up to 30% of diabetic patients. The first manifestation of DN in humans is microalbuminuria, which arises from the increased passage of albumin through the glomerular filtration barrier. Reactive oxygen species, inflammatory cytokines, and growth factors are key players in the context of damage to the glomerular filtration barrier. INTERVENTIONS: In this study the herbal combination Canephron(®) N, containing lovage root, rosemary leaves, and centaury herb, was administered to patients with DN to study the effects on microalbuminuria and overall oxidant/antioxidant status. An open study involving 59 patients with DN was performed to compare the effects of Canephron N administered concomitantly with standard antidiabetic therapy and an angiotensin-converting enzyme (ACE) inhibitor, with the standard therapy and ACE inhibitor treatment alone. RESULTS: After 6 months of therapy the level of microalbuminuria decreased significantly in the study group compared with the control group. Canephron N had a positive effect on the antioxidant defense status and lipid peroxidation levels. In addition, liver aminotransferase levels did not change. CONCLUSIONS: With respect to the excellent tolerability, the study results encourage use of the herbal combination as an add-on therapy in patients with DN.