ArticlesCorticosteroids in IgA nephropathy: a randomised controlled trial
Introduction
IgA nephropathy is the most common type of primary glomerulonephritis worldwide and is a major cause of end-stage renal disease1, 2 30–40% of patients with the disorder progress to dialysis or renal transplantation within 10–25 years.3, 4 Of the clinical and laboratory features included in multivariate analyses, persistent and severe proteinuria is the most important predictor of a poor outcome.5, 6, 7, 8, 9 There is still no accepted therapy for IgA nephropathy, although some beneficial effects from long-term use of corticosteroids have been reported in retrospective studies.10, 11 The results of randomised trials12, 13, 14, 15 are more equivocal. However, no firm conclusions can be reached about the usefulness of corticosteroids because these studies had small numbers of patients and short follow-up periods insufficient for this slowly progressive chronic disease.
In this prospective, randomised, multicentre study, we assessed the effects on renal function and the safety of a regimen based on the use of steroids for 6 months in patients with IgA nephropathy and urine protein excretion of 1·0–3·5 g daily.
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Study population
Between July, 1987, and September, 1995, 86 consecutive adult patients attending seven renal units in Italy were enrolled in the trial. The entry criteria were a histological diagnosis of IgA nephropathy with immunofluorescence showing mesangial IgA deposits, age 15–69 years, urinary protein excretion of 1·0–3·5 g daily for at least 3 months, and plasma creatinine concentrations of 133 μmol/L (1·5 mg/dL) or less. The onset of IgA nephropathy was arbitrarily defined as the first detection of
Study population
Of the 86 eligible patients, 43 were assigned steroid treatment and 43 standard treatment (figure 1). At presentation, the steroid and control groups were similar in distribution of age and sex, duration of IgA nephropathy, plasma creatinine concentration, creatinine clearance, urinary protein excretion, the proportion with hypertension, and the frequency and severity of renal histological lesions (table). Episodes of macroscopic haematuria at presentation were recorded in 25 patients; the mean
Discussion
We found better 5-year renal survival in patients with IgA nephropathy and moderate urine protein excretion treated with corticosteroids for 6 months than in patients receiving supportive therapy alone. We used the endpoints of a 50% or 100% increase from baseline plasma creatinine because this approach makes the assumption of linearity unnecessary, and data from patients with partial follow-up (censored data) can also be included. Plasma creatinine is a specific marker of deterioration in
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