Comparison of glucocorticoids alone and combined with cyclosporine a in patients with IgA nephropathy: a prospective randomized controlled trial.

Objective: The aim of this study was to investigate the effects of two different treatment regimes in patients with IgA nephropathy (IgAN): steroids alone and in combination with a medium dose of cyclosporine A (CsA).

Methods: Forty-eight IgAN patients 18-69 years of age with proteinuria >1.0 g/24 hours and an estimated glomerular filtration rate (eGFR) of >30 mL/min/1.73 m(2) were randomly given either steroids alone (methylprednisolone (MP) group; n=25) or steroids plus CsA treatment (combination group; n=23). The primary endpoint was the reduction of proteinuria by 50% or more of the baseline value. The secondary endpoint was an increase in the baseline serum creatinine level of 50% or a decrease in the baseline eGFR of 25%.

Results: After 12 months of treatment, all patients in the combination group and 87.50% of the patients in the MP group reached the primary endpoint. The complete remission rates in the combination group and MP group were 50.0% and 45.83%, respectively. The level of urinary protein excretion declined from 3.17 ± 3.25 g/24 hours to 0.36 ± 0.23 g/24 hours (p<0.001) in the combination group and from 2.60 ± 2.03 g/24 hours to 0.53 ± 0.71 g/24 hours (p<0.001) in the MP group. Two patients in the combination group reached the secondary endpoint, with a decrease in the eGFR of 25% from the baseline value, while no patients in the MP group achieved this goal. The patients in the combination group exhibited significant improvements in the eGFR after nine months (90.16 ± 28.78 vs. 80.46 ± 22.73 mL/min.1.73 m(2), p=0.011), while the patients in the MP group showed significant increases in the eGFR after six months of treatment (92.18 ± 22.71 to 81.63 ± 18.36 mL/min/1.73 m(2), p=0.019). Four patients (8.33%) developed severe pneumonia during treatment.

Conclusion: Both the full dose of steroids alone and combined treatment with steroids and a medium dose of CsA remarkably reduced the levels of proteinuria and ameliorated the renal function in the IgAN patients. Infection was the most serious complication during the treatment.