NCT01408836

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 1995

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1995

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
Last Updated

August 3, 2011

Status Verified

July 1, 2011

Enrollment Period

8.3 years

First QC Date

August 2, 2011

Last Update Submit

August 2, 2011

Conditions

Wegener's GranulomatosisMicroscopic Polyangiitis

Keywords

VasculitisANCATherapyPlasma exchangeImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • Renal recovery

    Three months

Secondary Outcomes (3)

  • End stage renal disease at 12 months

    12 months

  • Serum creatinine at 12 months

    12 months

  • Severe adverse events

    12 months

Study Arms (2)

1

EXPERIMENTAL

Plasma exchange x 7 over 14 days

Procedure: Plasma exchange

2

ACTIVE COMPARATOR

Methyl prednisolone 1g x 3

Drug: Intravenous methyl prednisoloneDrug: Methyl prednisolone

Interventions

Plasma exchangePROCEDURE

Plasma exchange

1
Intravenous methyl prednisoloneDRUG

Intravenous methyl prednisolone

2
Methyl prednisoloneDRUG

methyl prednisolone

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridge, CB22QQ, United Kingdom

Location

Related Publications (1)

  • Walsh M, Casian A, Flossmann O, Westman K, Hoglund 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.

    PMID: 23615499DERIVED

Related Links

MeSH Terms

Conditions

Granulomatosis with PolyangiitisMicroscopic PolyangiitisVasculitis

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSystemic VasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsPlasmapheresisBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Niels Rasmussen, MD

    Righospitalet, Copenhagen, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 3, 2011

Study Start

March 1, 1995

Primary Completion

June 1, 2003

Study Completion

December 1, 2003

Last Updated

August 3, 2011

Record last verified: 2011-07

Locations

GB(1)