Table 1.
Selected randomized controlled trials of IgA nephropathy
| Study | Study Design | Efficacy | Adverse Events | ||
|---|---|---|---|---|---|
| Rauen et al. (64) (STOP-IgA, IgA nephropathy) | Prospective, multicenter, RCT (2008–2011); sample size: 162; intervention: immunosuppression (Pozzi protocol steroids or oral CYC [1.5 mg/kg 3 mo, then oral AZA 1.5 mg/kg 3 yr] versus supportive care only; end point: clinical remission, decline in GFR; follow-up: 3 yr | No significant difference in the annual decline in eGFR or remission rates between the two groups | Immunosuppression (n=82) | Supportive care (n=80) | |
| SAEs | 29 (35%) | 21 (26%) | |||
| Serious infections | 8 (10%) | 3 (4%) | |||
| Total infections | 111 | 174 | |||
| Cancer | 2 (2%) | 0 | |||
| Diabetes/impaired glucose | 9 (11%) | 1 (1%) | |||
| Rauen et al. (6) (STOP-IgA, high GFR subgroup) | Prospective, multicenter, RCT (2008–2011); sample size: 162; intervention: immunosuppression corticosteroids (Pozzi protocol) versus supportive care; end point: clinical remission, decline in GFR; follow-up: 3 yr | Increased complete remission with steroid group (20% versus 3%) | Steroids (n=54) | Supportive care (n=55) | |
| SAEs | 12 (22%) | 14 (25%) | |||
| Serious infections | 4 (7%) | 2 (4%) | |||
| Total infections | 115 | 69 | |||
| Cancer | 0 | 0 | |||
| Diabetes/impaired glucose | 9 (17%) | 1 (2%) | |||
| Lv et al. (7) TESTING, IgA nephropathy) | Prospective, multicenter, RCT (2012–2015); sample size: 262; intervention: oral methylprednisone (0.6–0.8 mg/kg per d, taper after 2 mo) versus placebo; end point: ESKD or 40% decrease in GFR; follow-up: median 2.1 yr | Study terminated early second to excess SAEs in oral methylprednisone group | Oral methylprednisone (n=136) | Placebo (n=126) | |
| SAE | 20 (15%) | 4 (3%) | |||
| Serious infection | 11 (8%) | 0 | |||
| Pneumocystis jirovecii | 3 (2%) | 0 | |||
| Gastrointestinal SAE | 4 (3%) | 1 (1%) | |||
| Osteonecrosis | 2 (1%) | 0 | |||
| Hou et al. (65) (IgA nephropathy) | Prospective, multicenter, RCT (2010–2013); sample size: 176; intervention: MMF (1.5 g/d)+prednisone (0.4–0.6 mg/kg per d, taper) versus prednisone only (0.8–1.0 mg/kg per d, taper); end point: complete remission; follow-up: 12 mo | No difference in complete remission rate (48% versus 53%) | MMF+prednisone (n=87) | High-dose prednisone (n=88) | |
| SAE | 5 (6%) | 6 (7%) | |||
| Any infection | 27 (31%) | 20 (23%) | |||
| Serious infection | 3 (3%) | 4 (5%) | |||
| Diabetes (new) | 1 (1%) | 12 (14%) | |||
| Gastrointestinal | 7 (8%) | 10 (11%) | |||
| Osteonecrosis | 0 | 1 (1%) | |||
STOP-IgA, Supportive Versus Immunosuppressive Therapy for the Treatment of Progressive IgA Nephropathy; RCT, randomized controlled trial; CYC, cyclophosphamide; AZA, azathioprine; SAE, serious adverse event; TESTING, Therapeutic Evaluation of Steroids in IgA Nephropathy Global; MMF, mycophenolate mofetil.