Renal disease unrelated to SLE (e.g. diabetes mellitus, other glomerular or tubulointerstitial disease, renovascular disease), or transplanted kidney.
Estimated glomerular filtration rate (eGFR by MDRD) =20 mL/min per 1.73 m2 or serum creatinine >300 micromol/L (3.39 mg/dL) at screening.
Renal biopsy showing cellular or fibrocellular crescent in more than 25% of glomeruli.
CNS or other severe organ manifestation of lupus that necessitate aggressive immunosuppressive therapy on its own.
Co-morbidities that require corticosteroid therapy (e.g. asthma, inflammatory bowel disease).
Treatment with prednisolone (or prednisone, or equivalent) at >20 mg/D for over 4 weeks within the past 3 months.
Treatment with MMF at >1.5 g/D for over 4 weeks within the past 3 months.
Known hypersensitivity or intolerability to prednisolone (or prednisone, or equivalent), TAC, or MMF at a dose of 1.25 g or below per day.
Subjects who are already on treatment with TAC, cyclosporine or any other calcineurin inhibitor for over 4 weeks within the past 12 months.
Treatment with cyclophosphamide, leflunomide, or methotrexate for over 2 weeks, or use of biological agent(s) regardless of duration, within the past 6 months (Note: prior use of azathioprine, mizoribine, intravenous immunoglobulins and anti-malarials is allowed).
Uncontrolled hypertension with systolic BP >160 mmHg or diastolic BP >95 mmHg.
Women who are pregnant or breastfeeding.
Women with childbearing potential or their male partners, who refuse to use an effective birth control method

NCT02630628_exc_T1
Condition
Renal disease
NCT02630628_exc_T2
Negation
unrelated
NCT02630628_exc_T3
Condition
SLE
NCT02630628_exc_T4
Condition
diabetes mellitus
NCT02630628_exc_T5
Condition
tubulointerstitial disease
NCT02630628_exc_T6
Condition
glomerular disease
NCT02630628_exc_T7
Condition
renovascular disease
NCT02630628_exc_T8
Scope
diabetes mellitus, other glomerular or tubulointerstitial disease, renovascular disease
NCT02630628_exc_T9
Procedure
transplanted kidney
NCT02630628_exc_T10
Measurement
Estimated glomerular filtration rate
NCT02630628_exc_T11
Measurement
eGFR
NCT02630628_exc_T12
Value
=20 mL/min per 1.73 m2
NCT02630628_exc_T13
Measurement
serum creatinine
NCT02630628_exc_T14
Value
>300 micromol/L
NCT02630628_exc_T15
Value
3.39 mg/dL
NCT02630628_exc_T16
Procedure
Renal biopsy
NCT02630628_exc_T17
Condition
fibrocellular crescent
NCT02630628_exc_T18
Condition
llular o escent i
NCT02630628_exc_T19
Multiplier
more than 25% of glomeruli
NCT02630628_exc_T20
Scope
ellular or fibrocellular crescent
NCT02630628_exc_T21
Qualifier
CNS
NCT02630628_exc_T22
Condition
lupus
NCT02630628_exc_T23
Qualifier
organ manifestation
NCT02630628_exc_T24
Procedure
immunosuppressive therapy
NCT02630628_exc_T25
Scope
CNS or other severe organ manifestation
NCT02630628_exc_T26
Drug
corticosteroid therapy
NCT02630628_exc_T27
Condition
asthma
NCT02630628_exc_T28
Condition
inflammatory bowel disease
NCT02630628_exc_T29
Condition
Co-morbidities
NCT02630628_exc_T30
Scope
asthma, inflammatory bowel disease
NCT02630628_exc_T31
Drug
prednisolone
NCT02630628_exc_T32
Drug
prednisone
NCT02630628_exc_T33
Drug
isone, or alent) at
NCT02630628_exc_T34
Multiplier
>20 mg/D for over 4 weeks
NCT02630628_exc_T35
Temporal
past 3 months
NCT02630628_exc_T36
Scope
prednisolone (or prednisone, or equivalent)
NCT02630628_exc_T37
Drug
MMF
NCT02630628_exc_T38
Multiplier
>1.5 g/D for over 4 weeks
NCT02630628_exc_T39
Temporal
past 3 months
NCT02630628_exc_T40
Condition
hypersensitivity
NCT02630628_exc_T41
Condition
intolerability
NCT02630628_exc_T42
Drug
prednisolone
NCT02630628_exc_T43
Drug
prednisone
NCT02630628_exc_T44
Drug
one, or eq ent), TAC,
NCT02630628_exc_T45
Drug
TAC
NCT02630628_exc_T46
Drug
MMF
NCT02630628_exc_T47
Multiplier
1.25 g or below per day
NCT02630628_exc_T48
Scope
hypersensitivity or intolerability
NCT02630628_exc_T49
Scope
prednisolone (or prednisone, or equivalent), TAC, or MMF at a dose of 1.25 g or below per day
NCT02630628_exc_T50
Drug
TAC
NCT02630628_exc_T51
Drug
cyclosporine
NCT02630628_exc_T52
Drug
calcineurin inhibitor
NCT02630628_exc_T53
Multiplier
over 4 weeks
NCT02630628_exc_T54
Temporal
past 12 months.
NCT02630628_exc_T55
Scope
TAC, cyclosporine or any other calcineurin inhibitor
NCT02630628_exc_T56
Drug
cyclophosphamide
NCT02630628_exc_T57
Drug
leflunomide
NCT02630628_exc_T58
Drug
methotrexate
NCT02630628_exc_T59
Multiplier
2 weeks
NCT02630628_exc_T60
Procedure
biological agent
NCT02630628_exc_T61
Temporal
past 6 months
NCT02630628_exc_T62
Scope
cyclophosphamide, leflunomide, or methotrexate
NCT02630628_exc_T63
Scope
cyclophosphamide, leflunomide, or methotrexate for over 2 weeks, or use of biological agent(s)
NCT02630628_exc_T64
Negation
allowed
NCT02630628_exc_T65
Drug
azathioprine
NCT02630628_exc_T66
Drug
mizoribine
NCT02630628_exc_T67
Drug
immunoglobulins
NCT02630628_exc_T68
Drug
anti-malarials
NCT02630628_exc_T69
Scope
azathioprine, mizoribine, intravenous immunoglobulins and anti-malarials
NCT02630628_exc_T70
Condition
hypertension
NCT02630628_exc_T71
Qualifier
Uncontrolled
NCT02630628_exc_T72
Measurement
systolic BP
NCT02630628_exc_T73
Measurement
diastolic BP
NCT02630628_exc_T74
Value
>160 mmHg
NCT02630628_exc_T75
Value
>95 mmHg
NCT02630628_exc_T76
Scope
systolic BP >160 mmHg or diastolic BP >95 mmHg