Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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.
 
ClinicalTrials.gov Identifier: NCT01408836
Recruitment Status : Terminated (Completed)
First Posted : August 3, 2011
Last Update Posted : August 3, 2011
Sponsor:
Collaborators:
University Hospital Birmingham
Imperial College London
London North West Healthcare NHS Trust
University Hospitals, Leicester
Lund University Hospital
University Medical Center Groningen
Fundacio Clinic
Helsinki University
Information provided by:
Cambridge University Hospitals NHS Foundation Trust

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01408836


Locations
Layout table for location information
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
Helsinki University
Investigators
Layout table for investigator information
Study Director: Niels Rasmussen, MD Righospitalet, Copenhagen, Denmark
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
EUVAS homepage  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
ClinicalTrials.gov 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:
Vasculitis
ANCA
Therapy
Plasma exchange
Immunosuppression
Additional relevant MeSH terms:
Layout table for MeSH terms
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