Plasma Exchange for Renal Vasculitis

Phase 3TerminatedNCT01408836

Cambridge University Hospitals NHS Foundation Trust150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Wegener's Granulomatosis Microscopic Polyangiitis

Interventions

Plasma exchangePROCEDURE

Plasma exchange

Intravenous methyl prednisoloneDRUG

Intravenous methyl prednisolone

Methyl prednisoloneDRUG

methyl prednisolone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Addenbrooke's Hospital

Cambridge, Cambridge, United Kingdom

Outcomes

Primary Outcomes

Renal recovery

Time frame: Three months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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