Ace Initiates a Large Phase III Study For Levamisole
29 May 2007
ACE Pharmaceuticals today announced that the first patient has entered the Phase III trial also known as the Levamisole trial.
This trial was accepted by the EMEA by November 2006. The goal of this trial, which was accepted by the EMEA in November 2006, is to assess the efficacy and safety of a one year treatment with Levamisole. The child to be treated will receive Levamisole and a placebo on alternate days. The Levamisole is to prevent relapses or to prolong time to relapse after cessation of corticosteroids treatment in children with steroid sensitive Nephrotic Syndrome.
The study consists of an international, multi-centre, double-blind, placebo-controlled, Randomised Clinical Trial (RCT), followed by a cohort study using the infrastructure of the RCT. During the study, extensive pharmacokinetic values will be obtained in a sparse sampling schedule that has been accepted by EMEA as state of the art.
The study will enrol approximately 150 male and female patients between the ages of two and 18, reflecting the age of the primary Nephrotic Syndrome's disease population.
About Nephrotic Syndrome
Nephrotic Syndrome is a relatively rare disease that occurs in two to seven per 100,000 children. Nephrotic Syndrome might occur without apparent causes (especially in children) or as a result of a number of illnesses that can damage the glomeruli, the filtering units of the kidneys.
Nephrotic Syndrome is a chronically debilitating and life-threatening condition. It is marked by very high levels of protein in the urine (proteinuria), due to leakage of proteins through those damaged glomeruli from the blood into the urine. This severe loss of protein, typically leads to accumulation of fluid (oedema) and low levels of protein the blood (hypoproteinaemia).
Idiopathic Nephrotic Syndrome (INS) in children is normally treated with corticosteroids. While the majority of children with Nephrotic syndrome respond to corticosteroids, 70% experience relapses. In most of these children, corticosteroids therapy has to be repeated frequently, putting them at risk of the adverse effects of corticosteroids.
To reduce steroid toxicity in these patients, several alternative non-corticosteroid immunosuppressive agents have been proposed, of which cyclophosphamide and cyclosporine are used most commonly. The drawbacks of both drugs are their potential serious adverse effects including carcinogenesis, infertility, nephrotoxicity, hypertension and hirsutism. Levamisole also reduces steroid toxicity and it exhibits less serious side effects. Above all, Levamisole may be effective in patients in which cyclophosphamide and cyclosporine are not.
