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An open labeled, multicentre, randomised phase II trial to determine the activity of mycophenolate mofetil (CellCept®) for the treatment of severe lupus nephritis

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
Research Type
Interventional
Description
This is an open labeled multicentre randomised phase II trial designed to determine the activity of MMF in patients with severe lupus nephritis (WHO Class III and IV lupus nephritis).(1)(Appendix 3) Simon’s optimal two-stage design is used for the trial.(2) In the first stage, 9 patients will be randomly selected for treatment with MMF. However, if one or more patients were to respond, the trial will proceed to a second stage when 17 patients will be treated. A parallel group of randomly selected patients of equal number to the MMF arm will be treated with the standard iv cyclophosphamide treatment (active control arm). Response to treatment is defined as stabilisation or improvement in renal function; at least 50% decrease in haematuria but to less than 10 erythrocyte per high power field; and 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.
Study Information
RMK Priority Area
Research Level
Research Keyword
proliferative lupus nephritis, intravenous cyclophosphamide, mycophenolate mofetil, randomized controlled trial
Inclusion & Exclusion Criteria
Inclusion Criteria
Inclusion 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
Exclusion Criteria
Inclusion 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
Study Timeline
Expected / Actual Date Study Starts - First Enrolment of subject / Collecting data
Apr, 01 2000
Expected / Actual Date Study Completed
Oct, 01 2004
Expected / Actual Duration of Study Enrollment / Data Collection
234 weeks