Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Plank, C; Kalb, V; Hinkes, B; Hildebrandt, F; Gefeller, O; Rascher, W; Arbeitsgemeinschaft für Pädiatrische Nephrologie.
Cyclosporin A is superior to cyclophosphamide in children with steroid-resistant nephrotic syndrome-a randomized controlled multicentre trial by the Arbeitsgemeinschaft für Pädiatrische Nephrologie.
Pediatr Nephrol. 2008; 23(9): 1483-1493.
Doi: 10.1007/s00467-008-0794-1
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- Co-Autor*innen der Med Uni Graz
- Warncke Gert
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- Abstract:
- First line immunosuppressive treatment in steroid-resistant nephrotic syndrome in children is still open to discussion. We conducted a controlled multicentre randomized open label trial to test the efficacy and safety of cyclosporin A (CSA) versus cyclophosphamide pulses (CPH) in the initial therapy of children with newly diagnosed primary steroid-resistant nephrotic syndrome and histologically proven minimal change disease, focal segmental glomerulosclerosis or mesangial hypercellularity. Patients in the CSA group (n = 15) were initially treated with 150 mg/m(2) CSA orally to achieve trough levels of 120-180 ng/ml, while patients in the CPH group (n = 17) received CPH pulses (500 mg/m(2) per month intravenous). All patients were on alternate prednisone therapy. Patients with proteinuria >40 mg/m(2) per hour at 12 weeks of therapy were allocated to a non-responder protocol with high-dose CSA therapy or methylprednisolone pulses. At week 12, nine of the 15 (60%) CSA patients showed at least partial remission, evidences by a reduction of proteinuria <40 mg/h per m(2). In contrast, three of the 17 (17%) CPH patients responded (p < 0.05, intention-to-treat). Given these results, the study was stopped, in accordance with the protocol. After 24 weeks, complete remission was reached by two of the 15 (13%) CSA and one of the 17 (5%) CPH patients (p = n.s.). Partial remission was achieved by seven of the 15 (46%) CSA and two of the 15 (11%) CPH patients (p <0.05). Five patients in the CSA group and 14 patients in the CPH group were withdrawn from the study, most of them during the non-responder protocol. The number of adverse events was comparable between both groups. We conclude that CSA is more effective than CPH in inducing at least partial remission in steroid-resistant nephrotic syndrome in children.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adrenal Cortex Hormones - therapeutic use
- Child -
- Child, Preschool -
- Cyclophosphamide - adverse effects
- Cyclophosphamide - therapeutic use
- Cyclosporine - adverse effects
- Cyclosporine - therapeutic use
- Drug Resistance -
- Female -
- Follow-Up Studies -
- Genes, Wilms Tumor -
- Humans -
- Immunosuppressive Agents - therapeutic use
- Infant -
- Intracellular Signaling Peptides and Proteins - genetics
- Male -
- Membrane Proteins - genetics
- Mutation -
- Nephrotic Syndrome - drug therapy
- Nephrotic Syndrome - genetics
- Find related publications in this database (Keywords)
- child
- cyclophosphamide
- cyclosporin A
- focal segmental glomerulosclerosis
- minimal change nephropathy
- nephrotic syndrome