Glomerulonephritis, Membranous
Conditions
Keywords
membranous nephropathy, mycophenolate mofetil, cyclophosphamide, prednisone
Brief summary
Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects. In this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.
Interventions
DRUGmycophenolate mofetil orally 1000 mg twice a day (BID)
DRUGprednisone 0,5 mg/kg orally on alternate days
DRUGintravenous (i.v.) methylprednisolone 1000 mg, total 9
Sponsors
Hoffmann-La Roche
Radboud University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Membranous nephropathy * Serum creatinine (Screat)\> 1,5 mg/dl or ECC \< 70 ml/min or increase Screat \> 50% * Proteinuria \> 2 g/day
Exclusion criteria
* Systemic diseases * Pregnancy wish * Active infection * Liver dysfunction * Abnormal hematology lab * Unstable angina * Nonsteroidal anti-inflammatory agents (NSAIDs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| renal function (serum creatinine) | — |
| proteinuria | — |
Secondary
| Measure | Time frame |
|---|---|
| side effects | — |
| relapse rate | — |
Countries
Netherlands
Outcome results
None listed