Plasma Exchange for Renal Vasculitis (MEPEX)

This study has been terminated.

(Completed)

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

ClinicalTrials.gov Identifier:

NCT01408836

First received: August 2, 2011

Last updated: NA

Last verified: July 2011

History: No changes posted

Purpose

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	Intervention	Phase
Wegener's Granulomatosis Microscopic Polyangiitis	Procedure: Plasma exchange Drug: Intravenous methyl prednisolone Drug: Methyl prednisolone	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: granulomatosis with polyangiitis

MedlinePlus related topics: Vasculitis

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

Genetic and Rare Diseases Information Center resources: Granulomatosis With Polyangiitis Microscopic Polyangiitis ANCA-associated Vasculitis

U.S. FDA Resources

Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:

Renal recovery [ Time Frame: Three months ]

Secondary Outcome Measures:

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 ]


Enrollment:	150
Study Start Date:	March 1995
Study Completion Date:	December 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408836

Locations


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


Study Director:	Niels Rasmussen, MD	Righospitalet, Copenhagen, Denmark

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):

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.


ClinicalTrials.gov Identifier:	NCT01408836 History of Changes
Other Study ID Numbers:	BMH4-CT97-2328
Study First Received:	August 2, 2011
Last Updated:	August 2, 2011

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:


Vasculitis ANCA Therapy Plasma exchange Immunosuppression

Additional relevant MeSH terms:


Vasculitis Systemic Vasculitis Granulomatosis with Polyangiitis Microscopic Polyangiitis Vascular Diseases Cardiovascular Diseases 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 acetate Methylprednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on August 18, 2017

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