Plasma Exchange for Renal Vasculitis (MEPEX)
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| ClinicalTrials.gov Identifier: NCT01408836 |
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Recruitment Status :
Terminated
(Completed)
First Posted : August 3, 2011
Last Update Posted : August 3, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Wegener's Granulomatosis Microscopic Polyangiitis | Procedure: Plasma exchange Drug: Intravenous methyl prednisolone Drug: Methyl prednisolone | Phase 2 Phase 3 |
Primary systemic vasculitis associated with autoantibodies to neutrophil cytoplasmic antigens (ANCA), is the most frequent cause of rapidly progressive glomerulonephritis. Renal failure at presentation often progresses to end stage renal disease despite immunosuppressive therapy. We investigated whether the addition of plasma exchange was more effective than intravenous (IV) methyl prednisolone in the achievement of renal recovery for ANCA associated systemic vasculitis presenting with a serum creatinine above 500umol/l (5.8mg/dl).
137 patients with a new diagnosis of ANCA associated systemic vasculitis, serum creatinine above 500umol/l (5.8mg/dl) and a renal biopsy demonstrating a focal, necrotizing glomerulonephritis were randomized to receive seven plasma exchanges or IV methyl prednisolone 1000mg/day for three days. Both groups were treated with cyclophosphamide and oral prednisolone. The primary end-point was dialysis independence with a serum creatinine below 500umol/l (5.8mg/dl) at three months. Secondary end-points included renal and patient survival at 12 months and severe adverse event rates.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis |
| Study Start Date : | March 1995 |
| Actual Primary Completion Date : | June 2003 |
| Actual Study Completion Date : | December 2003 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Plasma exchange x 7 over 14 days
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Procedure: Plasma exchange
Plasma exchange |
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Active Comparator: 2
Methyl prednisolone 1g x 3
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Drug: Intravenous methyl prednisolone
Intravenous methyl prednisolone Drug: Methyl prednisolone methyl prednisolone |
- Renal recovery [ Time Frame: Three months ]
- End stage renal disease at 12 months [ Time Frame: 12 months ]
- Serum creatinine at 12 months [ Time Frame: 12 months ]
- Severe adverse events [ Time Frame: 12 months ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408836
| United Kingdom | |
| Addenbrooke's Hospital | |
| Cambridge, United Kingdom, CB22QQ | |
| Study Director: | Niels Rasmussen, MD | Righospitalet, Copenhagen, Denmark |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT01408836 History of Changes |
| Other Study ID Numbers: |
BMH4-CT97-2328 |
| First Posted: | August 3, 2011 Key Record Dates |
| Last Update Posted: | August 3, 2011 |
| Last Verified: | July 2011 |
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Vasculitis ANCA Therapy Plasma exchange Immunosuppression |
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Granulomatosis with Polyangiitis Microscopic Polyangiitis Vasculitis Vascular Diseases Cardiovascular Diseases Systemic Vasculitis Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Immune System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Prednisolone Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal |