Corticosteroids in IgA nephropathy: a randomised controlled trial

doi:10.1016/S0140-6736(98)03563-6

The Lancet

Volume 353, Issue 9156, 13 March 1999, Pages 883-887

https://doi.org/10.1016/S0140-6736(98)03563-6 Get rights and content

Summary

Background

IgA nephropathy is progressive in most cases and has no established therapy. In this randomised trial, we assessed the efficacy and safety of a 6-month course of steroids in this disorder.

Methods

Between July, 1987, and September, 1995, we enrolled 86 consecutive patients from seven renal units in Italy. Eligible patients had biopsy-proven IgA nephropathy, urine protein excretion of 1·0–3·5 g daily, and plasma creatinine concentrations of 133 μmol/L (1·5 mg/dL) or less. Patients were randomly assigned either supportive therapy alone or steroid treatment (intravenous methylprednisolone 1 g per day for 3 consecutive days at the beginning of months 1, 3, and 5, plus oral prednisone 0·5 mg/kg on alternate days for 6 months). The primary endpoint was deterioration in renal function defined as a 50% or 100% increase in plasma creatinine concentration from baseline. Analyses were by intention to treat.

Findings

Nine of 43 patients in the steroid group and 14 of 43 in the control group reached the primary endpoint (a 50% increase in plasma creatinine) by year 5 of follow-up (p<0·048). Factors influencing renal survival were vascular sclerosis (relative risk for 1-point increase in score 1·53, p=0·0347), female sex (0·22, p=0·0163), and steroid therapy (0·41, p=0·0439). All 43 patients assigned steroids completed the treatment without experiencing any important side-effects.

Interpretation

A 6-month course of steroid treatment protected against deterioration in renal function in IgA nephropathy with no notable adverse effects during followup. An increase in urinary protein excretion could be a marker indicating the need for a second course of steroid therapy.

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.

Section snippets

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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ArticlesCorticosteroids in IgA nephropathy: a randomised controlled trial

Summary

Background

Methods

Findings

Interpretation

Introduction

Section snippets

Study population

Study population

Discussion

Am J Med

Kidney Int

J Pediatr

Lancet

The commonest glomerulonephritis in the world: IgA nephropathy.

QJM

Follow-up evaluation of the first patients with IgA nephropathy described at Necker Hospital.

Contrib Nephrol

Therapeutic perspectives in mesangial IgA nephropathy.

Contrib Nephrol

Renal survival rate of IgA nephropathy.

Nephron

Prognostic indicators in idiopathic IgA mesangial nephropathy.

QJM

Proteinuria in IgA nephropathy.

Semin Nephrol

Prognostic indicators in childhood IgA nephropathy.

Nephron

Steroid therapy in IgA nephropathy: a prospective pilot study in moderate proteinuric cases.

QJM

Articles
Corticosteroids in IgA nephropathy: a randomised controlled trial