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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01408836
Other study ID # BMH4-CT97-2328
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received August 2, 2011
Last updated August 2, 2011
Start date March 1995
Est. completion date December 2003

Study information

Verified date July 2011
Source Cambridge University Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 150
Est. completion date December 2003
Est. primary completion date June 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Plasma exchange
Plasma exchange
Drug:
Intravenous methyl prednisolone
Intravenous methyl prednisolone
Methyl prednisolone
methyl prednisolone

Locations

Country Name City State
United Kingdom Addenbrooke's Hospital Cambridge

Sponsors (9)

Lead Sponsor Collaborator
Cambridge University Hospitals NHS Foundation Trust Fundacio Clinic, Helsinki University, Imperial College London, London North West Healthcare NHS Trust, Lund University Hospital, University Hospital Birmingham, University Hospitals, Leicester, University Medical Center Groningen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Renal recovery Three months No
Secondary End stage renal disease at 12 months 12 months No
Secondary Serum creatinine at 12 months 12 months No
Secondary Severe adverse events 12 months Yes
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