Ronald J. Falk, MD; Susan L. Hogan; Keith E. Muller, PhD; J. Charles Jennette, MD; Glomerular Disease Collaborative Network*
▪ Objective: To determine if deterioration in renal function could be ameliorated by adding cyclophosphamide to corticosteroid therapy in patients with progressive membranous glomerulopathy.
▪ Design: Randomized, controlled treatment trial. Patients were followed for a mean of 29.2 ± 17.1 months.
▪ Setting: Collaborative network of 120 university and private-practice nephrologists.
▪ Participants: Patients with membranous glomerulopathy whose renal function deteriorated (as evidenced by doubling of the serum creatinine level, a 50% fall in the glomerular filtration rate, or a sustained serum creatinine level of greater than 2.0 mg/dL [reciprocal creatinine value, 0.5], or whose nephrotic range proteinuria persisted in association with morbid complications. Of 156 patients with biopsy-proven membranous glomerulopathy, 36 became eligible for randomization. Twenty-six of these 36 patients were randomly assigned to receive one of the two treatments.
▪ Interventions: Pulse methylprednisolone, oral corticosteroids, and 6 months of intravenous cyclophosphamide or alternate-day corticosteroid therapy alone.
▪ Main Results: At entry, no statistical differences were found between the treatment groups in duration of renal disease, age, gender, serum creatinine level, 24-hour urine protein excretion, or biopsy stage. The groups showed no difference in mean arterial blood pressure during follow-up. Four of the 13 patients receiving corticosteroids alone and 4 of the 13 patients receiving corticosteroids plus intravenous cyclophosphamide progressed to end-stage renal disease during follow-up. Reciprocal creatinine values tested at 6-month intervals showed no statistical differences between treatment groups at any time point. The log of the 24-hour protein excretion values showed no statistical differences between treatment groups after treatment. The power to detect a substantial improvement in renal function, defined as a doubling of the reciprocal of the serum creatinine, at the 0.05 significance level was 0.92.
▪ Conclusions: Combination therapy with intravenous cyclophosphamide and corticosteroids, when compared with corticosteroid therapy alone, does not improve renal function in patients with progressive membranous glomerulopathy.
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Falk RJ, Hogan SL, Muller KE, Jennette JC, Glomerular Disease Collaborative Network*. Treatment of Progressive Membranous Glomerulopathy: A Randomized Trial Comparing Cyclophosphamide and Corticosteroids with Corticosteroids Alone. Ann Intern Med. 1992;116:438–445. doi: 10.7326/0003-4819-116-6-438
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Published: Ann Intern Med. 1992;116(6):438-445.
Autoimmune Kidney Disease, Nephrology, Rheumatology.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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