An open labeled, multicentre, randomised phase II trial to determine the activity of mycophenolate mofetil (CellCept®) for the treatment of severe lupus nephritis
MMF Trial
General Information
Study Information
Inclusion & Exclusion Criteria
1. SLE fulfilling ARA criteria(1)(Appendix 4)
2. Newly diagnosed and biopsy proven lupus nephritis WHO class Class III(a)-(b) and Class IV(a)-(c)(1)(Appendix 3)
3. Age above 16 years
4. Signed informed consent
Exclusion criteria
1. Known allergy to MMF or cyclophosphamide
2. Serum/plasma creatinine concentration of more than 200umol/l
3. Leucocyte count of less than 3.5 x 109/l
4. Evidence of systemic or localised major infection in the past two weeks
5. Use of any investigational drug or treatment within one month
6. Pregnancy and lactation
7. History of cancer
8. Active alcohol or other substance abuse
9. Active peptic ulcer disease
10. Presence of cresecents in more than 50% of glomeruli
11. Use of mycophenolate mofetil or cyclophosphamide within the last one month
1. SLE fulfilling ARA criteria(1)(Appendix 4)
2. Newly diagnosed and biopsy proven lupus nephritis WHO class Class III(a)-(b) and Class IV(a)-(c)(1)(Appendix 3)
3. Age above 16 years
4. Signed informed consent
Exclusion criteria
1. Known allergy to MMF or cyclophosphamide
2. Serum/plasma creatinine concentration of more than 200umol/l
3. Leucocyte count of less than 3.5 x 109/l
4. Evidence of systemic or localised major infection in the past two weeks
5. Use of any investigational drug or treatment within one month
6. Pregnancy and lactation
7. History of cancer
8. Active alcohol or other substance abuse
9. Active peptic ulcer disease
10. Presence of cresecents in more than 50% of glomeruli
11. Use of mycophenolate mofetil or cyclophosphamide within the last one month
Study Timeline
Gender :
The primary endpoint is response to treatment defined as :
1. Stabilisation or improvement in renal function and
2· At least 50% decrease in haematuria and less than 10 erythrocyte per high power field and
3· Significant improvement in proteinuria
- at least 50% reduction in proteinuria if nephrotic range at baseline but to less than 3g/day or
- to lg/day or less if baseline proteinuria was non-nephrotic
Stabilisation of renal function is defined as change in serum or plasma creatinine concentration of less than 20% compared with baseline concentration. Improvement in renal function is defined as reduction in serum or plasma creatinine of at least 20% compared with baseline concentration.
Nephrotic range proteinuria is defined as urinary protein excretion rate of more than 3 gram per day.
Secondary Outcome Measures:
1. Remission of nephritis :
Partial remission is defined as :
- absence of cellular casts and
- reduction in proteinuria to less than 1g per day and
- less than five erythrocytes per high power field of centrifuged urine and stabilisation or improvement of renal function
Complete remission is defined as
- absence of cellular casts and reduction in proteinuria to less than 0.3g per day and and less than five erythrocytes per high power field of centrifuged urine and and stabilisation or improvement of renal function
2. Improvement in SLEDAI score, complement concentration, dsDNA titer
3. Death
4. Commencement of permanent dialysis or renal transplantation
Permanent dialysis is defined as requirement for dialysis for longer than 3 months
Sites
Tengku Ampuan Rahimah Hospital (HTAR)
Tuanku Jaafar Hospital, Seremban
Sultanah Aminah Hospital (HSA) Johor Bharu
Kuala Lumpur Hospital
Clinical Research Centre (CRC), Kuala Lumpur Hospital
UNIVERSITY OF MALAYA (UM)
Ipoh Hospital
Team Members
Ampang Puteri Specialist Hospital
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