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.


CONCLUSIONS
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.
Department of Nephrology, , Zhongshan Hospital, Fudan University, China.
Hong
H
Liu
Xialian
X
Xu
Yi
Y
Fang
Jun
J
Ji
Xiaoyan
X
Zhang
Ming
M
Yuan
Chunfeng
C
Liu
Xiaoqiang
X
Ding
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D001706:Biopsy; D016572:Cyclosporine / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000187:drug effects; D005922:Glomerulonephritis, IGA / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007678:Kidney Glomerulus / Q000473:pathology; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage*; D008875:Middle Aged; D011446:Prospective Studies; D012074:Remission Induction; D016896:Treatment Outcome; D055815:Young Adult
D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D008775:Methylprednisolone