Plasma Exchange for Renal Vasculitis

Related Clinical Trial
Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis Hydroxychloroquine in ANCA Vasculitis Evaluation Vasculitis Illness Perception (VIP) Study Reproductive Health in Men and Women With Vasculitis Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis Impact of Vasculitis on Employment and Income Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases VCRC Tissue Repository Yellow Fever Vaccine in Patients With Rheumatic Diseases Journey of Patients With Vasculitis From First Symptom to Diagnosis One-Time DNA Study for Vasculitis Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. Clinical Transcriptomics in Systemic Vasculitis (CUTIS) The ANCA Vasculitis Questionnaire (AAV-PRO©) Vasculitis Pregnancy Registry VCRC Patient Contact Registry Patient-Reported Data Validation Study Educational Needs of Patients With Systemic Vasculitis Diagnostic Effectiveness of Virtual Bronchoscopy Alemtuzumab for ANCA Associated Refractory Vasculitis Interventional Cryotherapy for the Eradication of Benign Airway Disease (“ICE the BAD”) PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides Plasma Exchange for Renal Vasculitis PRO Development for ANCA Associated Vasculitis BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated Vasculitides Rituximab Vasculitis Maintenance Study Anti-Cytokine Therapy for Vasculitis Rituximab and Belimumab Combination Therapy in PR3 COMBIVAS American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis Low-dose Glucocorticoid Vasculitis Induction Study Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis. The Assessment of Prednisone In Remission Trial (TAPIR) – Patient Centric Approach Steroids and Methotrexate to Treat Systemic Vasculitis Efficacy Study of Two Treatments in the Remission of Vasculitis Assessment of Lung Inflammation in Patients With Atopic Asthma Using Positron Emission Tomography The Assessment of Prednisone In Remission Trial – Centers of Excellence Approach Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener’s) Rituximab for the Treatment of Wegener’s Granulomatosis and Microscopic Polyangiitis Cyclophosphamide and Prednisone Followed by Methotrexate To Treat Vasculitides Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener’s) or Microscopic Polyangiitis Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener’s) and Microscopic Polyangiitis Mycophenolate Mofetil for Treatment of Relapses of Wegener’s Disease or Microscopic Polyangiitis (MPA) Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) Daclizumab to Treat Wegener’s Granulomatosis An Open Label Pilot Study Examining the Use of Rituximab in Patients With Wegener’s Granulomatosis Who Have Experienced Disease Relapse on Standard Therapies Etanercept to Treat Wegener’s Granulomatosis Treatment of Wegener’s Granulomatosis With Cyclophosphamide Mycophenolate Mofetil to Treat Wegener’s Granulomatosis and Related Vascular Inflammatory Conditions Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener’s Granulomatosis Comparison of Treatments to Maintain Disease Remission in Patients With Wegener’s Granulomatosis and Related Vasculitis Syndromes Neutrophils as Prognostic Factors in Granulomatosis With Polyangiitis (Formerly Named Wegener’s Granulomatosis) Natural History of Granulomatosis With Polyangiitis: Clinical and Genetic Biomarkers of Airway Disease NoAAC PR-03 Study Analysis of Bronchial Tissue and Fluid in Patients With Wegener’s Granulomatosis TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener’s) or Microscopic Polyangiitis Study of One Protein Implicated in Wegener Disease Abatacept in Treating Adults With Mild Relapsing Wegener’s Granulomatosis Phase II Study on Gusperimus in Patients With Refractory Wegener’s Granulomatosis Etanercept for Wegener’s Granulomatosis Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener’s Granulomatosis

Brief Title

Plasma Exchange for Renal Vasculitis

Official Title

Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis

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.
    

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 Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Renal recovery

Secondary Outcome

 End stage renal disease at 12 months

Condition

Wegener's Granulomatosis

Intervention

Plasma exchange

Study Arms / Comparison Groups

 1
Description:  Plasma exchange x 7 over 14 days

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

150

Start Date

March 1995

Completion Date

December 2003

Primary Completion Date

June 2003

Eligibility 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.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Niels Rasmussen, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT01408836

Organization ID

BMH4-CT97-2328



Study Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

 University Hospital Birmingham

Study Sponsor

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


Verification Date

July 2011