The STARMEN trial: rethinking calcineurin inhibitor therapy in membranous nephropathy

The STARMEN trial postulated that in primary membranous nephropathy (pMN) treatment with tacrolimus plus rituximab would be superior to a traditional Ponticelli regimen of alternating cyclophosphamide and glucocorticoids. This was not the case. Significantly more remissions were achieved in cyclophosphamide-treated patients, and more of these were complete remissions. Considering these results with those of the Mentor trial, which compared rituximab with cyclosporine in pMN, we offer an evidence-based perspective on the role of calcineurin inhibition for pMN treatment. The STARMEN trial postulated that in primary membranous nephropathy (pMN) treatment with tacrolimus plus rituximab would be superior to a traditional Ponticelli regimen of alternating cyclophosphamide and glucocorticoids. This was not the case. Significantly more remissions were achieved in cyclophosphamide-treated patients, and more of these were complete remissions. Considering these results with those of the Mentor trial, which compared rituximab with cyclosporine in pMN, we offer an evidence-based perspective on the role of calcineurin inhibition for pMN treatment. The STARMEN trial indicates that alternating treatment with corticosteroids and cyclophosphamide is superior to sequential treatment with tacrolimus and rituximab in primary membranous nephropathyKidney InternationalVol. 99Issue 4PreviewA cyclical corticosteroid-cyclophosphamide regimen is recommended for patients with primary membranous nephropathy at high risk of progression. We hypothesized that sequential therapy with tacrolimus and rituximab is superior to cyclical alternating treatment with corticosteroids and cyclophosphamide in inducing persistent remission in these patients. This was tested in a randomized, open-label controlled trial of 86 patients with primary membranous nephropathy and persistent nephrotic syndrome after six-months observation and assigned 43 each to receive six-month cyclical treatment with corticosteroid and cyclophosphamide or sequential treatment with tacrolimus (full-dose for six months and tapering for another three months) and rituximab (one gram at month six). Full-Text PDF Open Access