Long-term results of two unconventional agents in steroid-dependent nephrotic children

Abstract

Children with steroid-dependent minimal change nephrotic syndrome are prone to serious steroid side effects. Alternative therapies, such as oral cyclophosphamide, may also have serious side effects. We conducted this novel prospective study to compare the long-term efficacies of levamisole and I.V. pulse cyclophosphamide as therapies with potentially fewer side effects. This study included 40 children with idiopathic steroid-dependent minimal change nephrotic syndrome (age 3-15 years; 31 boys and 9 girls). The patients were randomized into two equal groups. One group received levamisole 2.5 mg/kg on alternate days (levamisole group) while the other group received I.V. cyclophosphamide 500 mg/m2/month for six months (cyclophosphamide group). Prednisolone was gradually withdrawn. After stopping treatment, the number of patients that maintained remission was five (25%) in each group at six months, four (20%) versus two (10%) at one year and three (15%) versus one (5%) at two years in the levamisole and cyclophosphamide groups respectively, and one (5%) in each group at three and four years. The overall side effects were mild and both drugs were well tolerated. In view of the results, we recommend trial of levamisole before adopting other therapies with more serious side effects in such patients.

WITHDRAWN: Efficacy and Safety of Mycophenolate Mofetil Versus Levamisole in Children and Adolescents With Idiopathic Nephrotic Syndrome: Results of a Randomized Clinical Trial

“…9,11 A study comparing 6 months of oral levamisole treatment with monthly intravenous cyclophosphamide pulses observed equally rapid relapses after treatment discontinuation. 6 Treatment choices in this condition are driven not only by efficacy, but also by drug tolerability and safety considerations. Cyclophosphamide is associated with significant gonadotoxicity and might increase long-term cancer risk.…”

Clinical Course of Steroid Sensitive Nephrotic Syndrome in Children: Outcome and Outlook

“…Consistent with some previous reports, total infections level was moderate (up to 31.0-60.0%) [7,10,30]. The dominating type of these AEs was viral upper respiratory infection.…”

“…The hypertension was reported in approximately 11-37.5% of patients in the international literature [8,10,13,30] but only in 0-9.0% in our study. It is important that increase in blood pressure was detected after 4-5 weeks of treatment; it was controllable and limited in time to tapering PRED.…”

“…The hematological suppression with leukopenia was the most often observed and relatively complicated AEs under the alkylating agents treatment, which is reported by both our and international studies [3,14,20,30]. This effect is usually considered as dose-dependent, and many therapeutic strategies strive to achieve the leukopenia in order to induce the long-term remission.…”

Steroid sparing effect of a herbal preparation in steroid-dependent nephrotic syndrome

“…Although many immunosuppressants, such as cyclophosphamide and cyclosporine, have been used in these situations, with varying success [1][2][3], there are definite limitations to their efficacy not to mention their toxicity and cost [4]. Consequently, there is a need to explore other safer and efficacious options for treating children with SDNS.…”