Table 3.

Randomized controlled trials of maintenance therapy for lupus nephritis

Author	N	Follow-up duration	Histological classes of lupus nephritis	Induction regimen	Comparators	Primary end points	Adverse events
Contreras42	59	Beyond 5 yrs	WHO III, IV, Vb	IV CYC (0.5–1 g/m2) for 4–7 pulses	IV CYC (0.5–1 g/m2) every 3 months vs MMF (0.5–3 g/d) vs AZA (1–3 mg/kg/d)	Renal flare and renal function deterioration was significantly more common with CYC than MMF; MMF no better than AZA in the above outcomes	Nausea, vomiting, major infection rate and sustained amenorrhea more common with CYC than the other 2 groups
Moroni43	69	4 yrs	Class IV nephritis	Pulse MP + high dose prednisone + oral CYC for 3 mths	CSA (4 mg/kg/d) and taper to 2.5–3 mg/kg/d vs AZA 2 mg/kg/d	7 flares in CSA (19%) versus 8 flares in AZA (24%) group; reduction in proteinuria, blood pressure and creatinine clearance similar in both groups	Gum hypertrophy, hypertrichosis, hypertension, arthralgia, gastrointestinal symptoms more common with CSA; Infections and leucopenia more common with AZA
Houssiau44	105	53 mths	WHO class III, IV, Vc, Vd	Pulse MP + high dose prednisone + IV CYC (500 mg) × 6 doses	AZA (2 mg/kg/d) vs MMF (2 g/d)	Frequency of renal and extra-renal flares, doubling of serum creatinine similar in both groups	Infection rate similar; but drug-related cytopenias more common with AZA; withdrawal due to pregnancy was more common with MMF
Dooley45	227	2.1 yrs	ISN/RPS III, IV, V	High dose prednisone + either IV CYC (6 pulses) or MMF (3 g/d) × 6 mths	AZA (2 mg/kg/d) vs MMF (2 g/d)	Treatment failure, defined as the composite outcome of renal flares, doubling of serum creatinine or end stage renal failure, death or need for rescue therapy significantly less common in MMF than AZA group	No information yet

Abbreviations: N, number; yrs, years; mths, months; CYC, cyclophosphamide; MMF, mycophenolate mofetil; AZA, azathioprine; CSA, cyclosporin A.