Mycophenolate mofetil versus cyclosporine for remission maintenance in nephrotic syndrome

Abstract

We performed a multi-centre randomized controlled trial to compare the efficacy of mycophenolate mofetil (MMF) to that of cyclosporine A (CsA) in treating children with frequently relapsing nephrotic syndrome and biopsy-proven minimal change disease. Of the 31 randomized initially selected patients, seven were excluded. The remaining 24 children received either MMF 1200 mg/m 2 per day (n=12) or CsA 4-5 mg/kg per day (n=12) during a 12-month period. Of the 12 patients in the MMF group, two discontinued the study medication. Evaluation of the changes from the baseline glomerular filtration rate showed an overall significant difference in favour of MMF over the treatment period (p=0.03). Seven of the 12 patients in the MMF group and 11 of the 12 patients in the CsA group remained in complete remission during the entire study period. Relapse rate in the MMF group was 0.83/year compared to 0.08/year in the CsA group (p=0.08). None of the patients reported diarrhea. Pharmacokinetic profiles of mycophenolic acid were performed in seven patients. The patient with the lowest area under the curve had three relapses within 6 months. In children with frequently relapsing minimal change nephrotic syndrome, MMF has a favourable side effect profile compared to CsA; however, there is a tendency towards a higher relapse risk in patients treated with MMF.

WITHDRAWN: Enteric coated mycophenolate sodium combined with lowdose steroid as first line therapy in minimal change nephrotic syndrome: an open label randomized controlled study

“…Compared with calcineurin inhibitors such as cyclosporine A, MMF has a better side effect profile. Patients on MMF had better eGFR than those on cyclosporine A [7]. Hence, MMF would be a good alternative immunosuppressant, particularly in patients who had evidence of calcineurin inhibitor toxicity [15].…”

“…Subsequently it was also reported in randomized studies to induce remission of proteinuria in IgA nephropathy [4,5], and achieve equivalent therapeutic efficacy when compared with standard Ponticelli regimen in idiopathic membranous nephropathy [6]. More recently, mycophenolate is reported to be a less toxic adjuvant agent for remission maintenance in childhood-onset relapsing or steroid-dependent MCD compared with cyclosporine [7][8][9]. In adults, mycophenolate is also shown to be a promising alternative treatment in a case series of 5 subjects [10].…”

Risk Factors for Cyclosporin A Nephrotoxicity in Children with Steroid-Dependant Nephrotic Syndrome

“…As new treatments such as mycophenolate mofetil and rituximab become available (2,36,37), indications for follow-up renal biopsies aimed at detecting early signs of CsAN are rapidly decreasing. Nonetheless, our data suggest that if patients' disease is well controlled with low dosages of CsA and if they do not develop hypertension, then a renal biopsy can probably be postponed to after 4 to 5 yr of treatment.…”

Mycophenolate Mofetil versus Cyclosporin A in Children with Frequently Relapsing Nephrotic Syndrome

“…Several small studies with limited statistical power have shown that MMF has steroid-sparing effects and reduces relapse rates in patients with FR-SSNS, albeit with varying efficacy. [11][12][13][14][15][16][17][18] We studied efficacy and safety of MMF in patients with FR-SSNS in comparison with CsA in a prospective randomized multicenter open-label crossover trial.…”