Low-dose corticosteroid and mycophenolate for primary treatment of minimal change disease

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. 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, eight patients in Group 1 vs seven 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. Both treatment regimes were well tolerated but there were more patient reported adverse effects in the standard-dose prednisolone group. CONCLUSION: 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.