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Plasma Exchange for Renal Vasculitis (MEPEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01408836
Recruitment Status : Terminated (Completed)
First Posted : August 3, 2011
Last Update Posted : August 3, 2011
University Hospital Birmingham
Imperial College London
London North West Healthcare NHS Trust
University Hospitals, Leicester
Lund University Hospital
University Medical Center Groningen
Fundacio Clinic Barcelona
University of Helsinki
Information provided by:
Cambridge University Hospitals NHS Foundation Trust

Brief Summary:
The purpose of this study is to test whether additional therapy with plasma exchange improves the chances of kidney recovery in severe kidney vasculitis.

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

Detailed Description:

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.

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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
Experimental: 1
Plasma exchange x 7 over 14 days
Procedure: Plasma exchange
Plasma exchange

Active Comparator: 2
Methyl prednisolone 1g x 3
Drug: Intravenous methyl prednisolone
Intravenous methyl prednisolone

Drug: Methyl prednisolone
methyl prednisolone

Primary Outcome Measures :
  1. Renal recovery [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. End stage renal disease at 12 months [ Time Frame: 12 months ]
  2. Serum creatinine at 12 months [ Time Frame: 12 months ]
  3. Severe adverse events [ Time Frame: 12 months ]

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01408836

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United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CB22QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
University Hospital Birmingham
Imperial College London
London North West Healthcare NHS Trust
University Hospitals, Leicester
Lund University Hospital
University Medical Center Groningen
Fundacio Clinic Barcelona
University of Helsinki
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Study Director: Niels Rasmussen, MD Righospitalet, Copenhagen, Denmark
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT01408836    
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
Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Plasma exchange
Additional relevant MeSH terms:
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Granulomatosis with Polyangiitis
Microscopic Polyangiitis
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
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal