Plasma Exchange for Renal Vasculitis (MEPEX)

This study has been terminated.
(Completed)
Sponsor:
Collaborators:
University Hospital Birmingham
Imperial College London
North West London Hospitals NHS Trust
University Hospitals, Leicester
Lund University Hospital
University Medical Centre Groningen
Fundacio Clinic
Helsinki University
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01408836
First received: August 2, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted

August 2, 2011
August 2, 2011
March 1995
June 2003   (final data collection date for primary outcome measure)
Renal recovery [ Time Frame: Three months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • End stage renal disease at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Serum creatinine at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Severe adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Plasma Exchange for Renal Vasculitis
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Wegener's Granulomatosis
  • Microscopic Polyangiitis
  • Procedure: Plasma exchange
    Plasma exchange
  • Drug: Intravenous methyl prednisolone
    Intravenous methyl prednisolone
  • Drug: Methyl prednisolone
    methyl prednisolone
  • Experimental: 1
    Plasma exchange x 7 over 14 days
    Intervention: Procedure: Plasma exchange
  • Active Comparator: 2
    Methyl prednisolone 1g x 3
    Interventions:
    • Drug: Intravenous methyl prednisolone
    • Drug: Methyl prednisolone
Walsh M, Casian A, Flossmann O, Westman K, Höglund P, Pusey C, Jayne DR; European Vasculitis Study Group (EUVAS). Long-term follow-up of patients with severe ANCA-associated vasculitis comparing plasma exchange to intravenous methylprednisolone treatment is unclear. Kidney Int. 2013 Aug;84(2):397-402. doi: 10.1038/ki.2013.131. Epub 2013 Apr 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
December 2003
June 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01408836
BMH4-CT97-2328
No
Not Provided
Cambridge University Hospitals NHS Foundation Trust
  • University Hospital Birmingham
  • Imperial College London
  • North West London Hospitals NHS Trust
  • University Hospitals, Leicester
  • Lund University Hospital
  • University Medical Centre Groningen
  • Fundacio Clinic
  • Helsinki University
Study Director: Niels Rasmussen, MD Righospitalet, Copenhagen, Denmark
Cambridge University Hospitals NHS Foundation Trust
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP