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CONNEXI 2015-05 Nephrologie Dialyse Transplantation

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  • Patienten
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  • Peritoneal
  • Dialysis
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Retrospektive vom Nephrologischen Seminar in Heidelberg, Erfurter Dialysefachtage, Expertenmeeting Dialyse in Erfurt, ERA EDTA in London 2015

ERA-EDTA – News A Long

ERA-EDTA – News A Long Acting Intravenous Calcimimetic (AMG416) for Secondary Hyperparathyroidism in Haemodialysed Patients Held jointly with A common side effect of chronic kidney disease (CKD) is secondary hyperparathyroidism (sHPT). It is believed that over 90 % of dialysis patients develop an sHPT during the course of their terminal renal insufficiency – even if in a different form [1]. Disorders of mineral metabolism, including secondary hyperparathyroidism, contribute to renal osteodystrophy and vascular and other extraskeletal calcification in chronic kidney disease. A 12-week open-label phase two dose escalation and long-term follow-up study of AMG416, a synthetic long acting peptide calcimimetic, in 37 haemodia lysed patients resulted in sustained reductions in parathyroid hormone (PTH), albumin adjusted calcium (cCa) and phosphate (Pi). Herein we report the results of two phase three studies designed to assess the safety and efficacy of AMG416 in patients receiving haemodialysis with inadequately controlled sHPT. 53 rd Congress Vienna Held jointly with Austria ERA-EDTA Methods We conducted two parallel, phase 3, randomized, placebo-controlled 26-week trials in 1023 haemodialysed patients with moderate to severe sHPT (PTH >400 pg/mL) to evaluate the effect of AMG416 on serum PTH concentrations and other laboratory parameters of mineral metabolism. The primary efficacy endpoint was the proportion of patients achieving >30 % reduction in PTH. Secondary endpoints included the proportion of patients with serum PTH ≤300 pg/mL, and percent reductions in serum PTH, cCa, Pi, and cCa x Pi. Results Patients randomized to AMG416 were significantly more likely to achieve the primary efficacy endpoint (74.7 % vs. 8.9 %). The proportion of patients achieving PTH ≤300 pg/mL was also significantly higher in AMG416 treated subjects (51.5 % vs. 4.9 %) despite similar baseline mean PTH values – 724 pg/ml and 716 pg/ml respectively. Serum cCa and Pi decreased significantly, as did fibroblast growth factor 23. Despite more provision of Ca and calcitriol (or other active vitamin D compounds), two-thirds of AMG416-treated patients experienced >30 % reduction in serum concentrations FGF23 compared with 30 % of placebo-treated patients. Hypocalcaemia occurred more frequently in AMG416 treated patients (7.0 % vs. 0.2 %), as era-edta2016.org www

ERA-EDTA – News Interview mit Prof. Dr. John Cunningham, The Royal Free Hospital, University College London Welche Vorteile sehen Sie für ein intravenös zu applizierendes Calcimimetikum? Die lange Wirkdauer erlaubt die dreimal wöchentliche Gabe während der Dialyse, dadurch erreicht man eine hohe Adhärenz bei den Patienten und auch die gastrointestinalen Nebenwirkungen könnten sich verringern. Verglichen mit dem oralen Calcimimetikum Cinacalcet, wie effektiv ist AMG416 in der PTH-Reduktion? Erste Anzeichen deuten darauf hin, dass es zumindest ebenso gut, wenn nicht ein bisschen effektiver PTH senkt als Cinacalcet. Wie warten noch auf die vollständige Datenauswertung einer direkten Vergleichsstudie (head-to-head study), die kürzlich abgeschlossen wurde. Haben Sie in der Studie Subgruppen analysiert? Profitieren bestimmte Patienten mehr als andere? Es gab es keine therapierefraktären Subgruppen. Alle Schweregrade der Erkrankung haben gut auf die Behandlung angesprochen. did serum cCa

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