Table 3.
The STOP Trial: Summary of protocol and results52
| Variable | Supportive Care, n=80 | Supportive Care Plus Immunosuppression, n=82 | P Value |
|---|---|---|---|
| Age, yr | 45.8±12.5 | 42.8±13.1 | NS |
| eGFR, ml/min per 1.73 m2 | 57.4±24.9 | 61.1±29.0 | NS |
| Proteinuria, g/d | 1.6±0.7 | 1.8±0 | NS |
| Systolic BP | 131±14.0 | 127±8.5 | NS |
| Diastolic BP | 78±7.0 | 77±7.0 | NS |
| Outcomes | |||
| Full clinical remission, (%) | 4/80 (5) | 14/82 (17) | 0.01 |
| eGFR decrease >15 ml/min per 1.73 m2 | 22/80 (28) | 21/82 (26) | NS |
| AEs | |||
| Patients with one or more serious AEs | 21/80 | 29/80 | NS |
| Total no. of events of infection | 111 | 174 | 0.07 |
| Impaired glucose tolerance or diabetes mellitus | 1 | 9 | 0.02 |
Data are reported as mean±SD. Supportive care: optimized doses of RASBs to maintain BP<125/75 mmHg and in patients who are persistently proteinuric, maximum approved daily dose or highest dose without unacceptable side effects. Immunosuppression: (1) in 55 patients with eGFR of >60 ml/min per 1.73 m2, glucocorticoid for 6 months (1 g/d intravenous methylprednisolone for 3 days at months 1, 3, and 5 and 0.5 mg/kg oral prednisolone on the other days); and (2) in 27 patients with eGFR>30 and <59 ml/min per 1.73 m2, 1.5 mg/kg per day cyclophosphamide for 3 months followed by 1.5 mg/kg per day azathioprine for months 4–36 plus 40 mg/d oral prednisolone tapered to discontinuation at month 36. Full clinical remission: <0.2 mg urinary protein/1 mg creatinine with stable eGFR.