Enteric coated Mycophenolate Sodium combined with low-dose steroid as first time therapy in minimal change nephrotic syndrome: an open label randomized controlled study

Abstract

Background: Mycophenolate has been shown to be effective in glomerular disease. However, the role of mycophenolate in the first-line treatment of adult onset idiopathic minimal change disease (MCD) has not been systematically studied in a randomized fashion.

Materials and Methods: 20 adult patients with biopsy proven MCD were recruited and randomly assigned to recevie either enteric coated Mycophenolate Sodium (EC-MPS) plus low dose prednisolone (Group 1: Prednisolone 0.25 mg/kg/day, n = 10) or standard dose prednisolone (Group 2: Prednisolone 1 mg/kg/day, n = 10).

Results: After 24 weeks of therapy, 80% (n = 8) of patients in Group 1 vs 70% (n = 7) of patients in Group 2 achieved complete remission (p = 0.606). Both groups showed a significant reduction of urine protein excretion (p < 0.05) and increased serum albumin (p < 0.001) vs baseline levels. However, no significant between-group differences were demonstrated. The relapse rate was also similar in both groups (Group 1: 10% vs Group 2: 10%). EC-MPS treatment was well tolerated but 5 out of 10 patients from the standard-dose prednisolone group reported adverse reaction towards the assigned treatment.

Conclusions: EC-MPS plus low dose prednisolone is non-inferior to standard-dose prednisolone therapy in inducing clinical remission and preventing relapse in adult onset idiopathic MCD and is associated with better tolerability and less adverse effects. This trial is registered with the ClinicalTrials.gov number NCT01185197.