IgA nephropathy is the most common primary glomerulonephritis in the world. Because of the poor treatment effect in advanced patients, it is still the main cause of maintenance dialysis. Current immunosuppressive therapy is still controversial, especially to those progressive IgA nephropathy with eGFR\<50ml/min. Leflunomide is widely used in the treatment of rheumatic diseases, such as rheumatoid arthritis and lupus nephritis, it's serum concentration will not be affected by renal function, and it also has antiviral effect. There are two randomized controlled trials and a retrospective study suggesting that leflunomide combined with glucocorticoids can effectively control urinary protein compared with glucocorticoids or conservative treatment, but these three studies are not specifically targeted at patients with estimated Glomerular Filtration Rate(eGFR) \< 50ml/min. Investigators will perform a prospective, open-label, randomized, controlled trial to evaluate the efficacy and safety of leflunomide and low dose glucocorticoids therapy in progressive IgA nephropathy with eGFR\<50ml/min
all the participants enrolled in the study will be randomly assigned in a 1:1 ratio, the experimental group will receive leflunomide + low dose glucocorticoids therapy on the basis of conservative treatment, while the control group receive conservative treatment only. Conservative treatment is defined as the treatment of delaying the progress of renal function, including low-protein diet supplemented with ketoacid therapy, Renin Angiotensin system (RAS) inhibitor, blood pressure control, lipid-regulating therapy and antiplatelet aggregation therapy. The course of treatment will last one year, then the leflunomide+glucocorticoids group will continue the conservative treatment. Participants will be follow-up at least 98 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Leflunomide plus low dose glucocorticoids to have the immunosuppressive therapy to those progressive IgA nephropathy with eGFR\<50ml/min
Xu Yi
Shenzhen, Guangdong, China
RECRUITINGrenal survival rate
50% increase in serum creatinine compared with the baseline level or End Stage Renal Disease(ESRD)
Time frame: at least 96 weeks
proteinuria
changes in proteinuria compared to the baseline
Time frame: at least 96 weeks
eGFR
extent of eGFR decline compared with the baseline and annual decline rate
Time frame: at least 96 weeks
complete remission rate
Complete Remission (CR): proteinuria \< 1.0g / 24hr, Scr stable (Scr increase ≤ 15% baseline level)
Time frame: at least 96 weeks
partial remission rate
Partial Remission (PR): proteinuria in 1.0-3.5g/24hr range and decrease more than 50%, Scr stable (Scr increased ≤ 15% baseline level)
Time frame: at least 96 weeks
no response rate
No Response (NR):proteinuria \> 3.5g/24hr or decrease less than 50% of baseline , with or without deterioration of renal function
Time frame: at least 96 weeks
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