Microscopic Polyangiitis Clinical Trial
— MEPEXOfficial title:
Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis
The purpose of this study is to test whether additional therapy with plasma exchange improves the chances of kidney recovery in severe kidney vasculitis.
Status | Terminated |
Enrollment | 150 |
Est. completion date | December 2003 |
Est. primary completion date | June 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of Wegener's granulomatosis or microscopic polyangiitis, using criteria adapted by EUVAS from the disease definitions of the Chapel Hill consensus conference - Biopsy proven, pauci-immune, necrotising and/or crescentic glomerulonephritis, in the absence of other defined glomerulopathy - Severe renal impairment defined by: (i) oliguria (<400ml/24hr), or (ii) intention to commence dialysis within 48 hours of admission, and (iii) creatinine >500umol/l (5.8mg/dl). Exclusion Criteria: - Age under 18 or over 80 years - Inadequate contraception in women of child-bearing age - Pregnancy - Previous malignancy - Hepatitis B antigenaemia, anti-hepatitis C virus or anti-human immunodeficiency virus antibody - Diagnosis of Churg-Strauss syndrome, Henoch-Schönlein purpura, rheumatoid vasculitis, mixed essential cryoglobulinaemia or systemic lupus erythematosus - Circulating anti-GBM antibodies or linear IgG staining of the GBM on renal biopsy - Life-threatening non-renal manifestations of vasculitis, including alveolar hemorrhage requiring mechanical ventilation within 24 hours of admission - On dialysis for > two weeks prior to entry - Creatinine > 200umol/l (2.3mg/dl) one year or more before entry - A second clearly defined cause of renal failure - Previous episode of biopsy-proven necrotising and/or crescentic glomerulonephritis - > two weeks treatment with cyclophosphamide or azathioprine - > 500mg IV methyl prednisolone - Plasma exchange within the preceding year - > three months treatment with oral prednisolone - Allergy to study medications. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Addenbrooke's Hospital | Cambridge |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust | Fundacio Clinic, Helsinki University, Imperial College London, London North West Healthcare NHS Trust, Lund University Hospital, University Hospital Birmingham, University Hospitals, Leicester, University Medical Center Groningen |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Renal recovery | Three months | No | |
Secondary | End stage renal disease at 12 months | 12 months | No | |
Secondary | Serum creatinine at 12 months | 12 months | No | |
Secondary | Severe adverse events | 12 months | Yes |
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