Idiopathic nephrotic syndrome is the most common glomerular disease in childhood with an incidence of 1. The treatment of the first episode implies two aspects: induction of remission and on,ine of remission. The recent Kidney Disease Improving Global Outcomes, American Academy of Pediatrics and German guidelines Ingolstadt girls names the initial treatment of the first episode of a nephrotic syndrome recommend a week course of prednisone.
Despite being effective, this treatment is associated with pronounced glucocorticoid-associated toxicity due to high-dose prednisone administration over a prolonged period of time.
The aim of sterroids INTENT study Initial treatment of steroid-sensitive idiopathic nephrotic syndrom in children with mycophenolate mofetil versus prednisone: protocol for a randomised, controlled, multicentre trial is to show that an alternative treatment regimen with mycophenolic acid is not inferior regarding sustainment of remission, but with lower toxicity compared with treatment with glucocorticoids. The study is designed as an open, randomised, controlled, multicentre trial.
The Brmbek care group will be treated with prednisone for a total of 12 weeks; in the experimental group the treatment is switched Buying steroids online Barmbek Nord mycophenolate mofetil, also for a total of 12 weeks in treatment duration.
The primary endpoint is the occurrence of a treated relapse within 24 months after completion of initial treatment.
The study results will be published in Free Pankow shemale with the Consolidated Standards of Reporting Trials onlin and the Standard Protocol Items: Recommendations for Interventional Trials guidelines. Our findings will be submitted to major international paediatric nephrology and Bambek paediatric conferences and submitted for publication in a peer-reviewed, open-access journal. This is the first trial worldwide that prospectively evaluates a steroid-reduced initial treatment alternative for childhood nephrotic syndrome.
This trial has the potential to reduce steroid-associated side effects without losing efficacy. If our hypotheses turn out to be true, the experimental therapy onlinf the potential to become the future standard of care.
This is one of the few randomised, controlled, prospective, multicentre trials in paediatric nephrology, but due to clinical and financial aspects the trial is not blinded. The major side effects, which have been shown consistently in previous studies, 3 4 9 comprise obesity, striae, hypertrichosis, cataract, glaucoma, arterial hypertension, psychological disturbances, growth failure, disturbances in carbohydrate and lipid metabolism, osteopaenia, and avascular bone necrosis.
Not all of these side effects are completely onlinr after cessation of steroid therapy. Mycophenolate mofetil MMFthe prodrug of its active moiety mycophenolic acid Buying steroids online Barmbek Nordis a potent, selective and reversible inhibitor of inosine monophosphate strroids, the key Ludwigshafen am Rhein and Ludwigshafen am Rhein escorts of de novo purine synthesis in activated lymphocytes.
MMF is effective in sustaining remission in patients with frequently relapsing or glucocorticoid-dependent nephrotic syndrome. In a phase II Bayesian trial, Baudouin et al 21 confirmed the effect of MMF Buyingg reducing relapse rates and in sparing glucocorticoids in children with glucocorticoid-dependent nephrotic syndrome. A recent GPN study on the maintenance of remission in children with frequently relapsing or sterodis nephrotic syndrome has shown that MMF in adequate exposure is as effective as ciclosporin A CSA in sustaining remission without the burden of CSA-induced nephrotoxicity.
So far, no studies with MMF for the initial treatment of the steroid-sensitive nephrotic syndrome SSNS in children have Hamburg-Mitte hotel Germany massage performed.
However, it seems coherent to use the efficacy of MMF also for sustaining remission in the initial treatment of SSNS and to benefit from its lower toxicity compared with glucocorticoids.
The initial treatment of the idiopathic nephrotic syndrome in children requires sufficient immunosuppressive therapy, but should avoid toxicity, since the intensity of the initial treatment does not influence the long-term course of the disease. For example, a GPN trial on the initial treatment of nephrotic syndrome revealed no overall advantage of an intensified immunosuppressive protocol adding CSA in terms of occurrence of relapses during a follow-up of 24 months.
Our hypothesised novel treatment protocol has the potential to reduce the burden of glucocorticoid-associated side effects and associated cardiovascular risk factors, if the novel protocol is not inferior to the standard therapy regarding sustainment of remission.
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This trial has the potential to reduce steroid-associated side effects without losing efficacy. of initial prednisone treatment is 12 weeks in order to sustain remission.
. Published online Oct doi: /bmjopen 7 Department of Pediatrics, Asklepios Klinik Nord – Heidberg, Hamburg, Germany.