NCT00430105

Brief Summary

A comparison of intermittent pulsed cyclophosphamide to daily oral cyclophosphamide for the treatment of ANCA-associated systemic vasculitides with kidney involvement. Performed by the European Vasculitis Study group.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 1998

Longer than P75 for phase_2

Status
completed

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

February 1, 1998

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
Last Updated

February 1, 2007

Status Verified

January 1, 2007

First QC Date

January 31, 2007

Last Update Submit

January 31, 2007

Conditions

ANCA Associated Systemic VasculitisWegener's GranulomatosisMicroscopic Polyangiitis

Keywords

VasculitisANCAWegener's granulomatosisRenal vasculitisCyclophosphamide

Outcome Measures

Primary Outcomes (1)

  • Disease free period, time from remission to relapse or study end.

Secondary Outcomes (3)

  • Adverse events

  • Vasculitis Damage Index

  • Cumulative exposure to cyclophosphamide

Interventions

cyclophosphamideDRUG

Eligibility Criteria

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

You may qualify if:

  • A new diagnosis of WG, MP or renal-limited vasculitis (RLV) (appendix 5). Patients not previously treated with cytotoxic drugs will be permitted.
  • Renal involvement attributable to active WG, MP or RLV with at least one of the following:
  • elevated serum creatinine between 150 and 500 umol/l.
  • biopsy demonstrating necrotizing glomerulonephritis.
  • red cell casts.
  • haematuria with \>30 red blood cells/high powered field and proteinuria \> 1g/24hr.
  • ANCA positivity or confirmatory histology or both (appendix 5). ANCA positivity requires a typical CANCA pattern by indirect immunofluorescence (IIF), (preferably confirmed by anti-PR3 ELISA), or the presence of PR3-ANCA or MPO-ANCA determined by ELISA, PANCA requires confirmation by anti-MPO ELISA \[6\]. (Central review of ANCA serology and histology will be performed).
  • Age 18-80 years.

You may not qualify if:

  • More than two weeks treatment with cyclophosphamide (CYC) or other cytotoxic drug within previous year or with oral corticosteroids (OCS) for more than 4 weeks. If the patient has received \>1.0g of methyl-prednisolone prior to the study start, discuss with trial co-ordinator.
  • Co-existence of another multisystem autoimmune disease, e.g. SLE.
  • Hepatitis Be antigen positive or Hepatitis C antibody positive.
  • Known HIV positivity (HIV testing will not be a requirement for this trial).
  • Serum creatinine \> 500umol/l (consider MEPEX trial).
  • Immediately life-threatening organ manifestations (e.g. lung haemorrhage or dialysis dependence).
  • Previous malignancy (usually exclude unless agreed with trial co-ordinator).
  • Pregnancy or inadequate contraception if female.
  • Anti-GBM antibody positivity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Morgan MD, Szeto M, Walsh M, Jayne D, Westman K, Rasmussen N, Hiemstra TF, Flossmann O, Berden A, Hoglund P, Harper L; European Vasculitis Society. Negative anti-neutrophil cytoplasm antibody at switch to maintenance therapy is associated with a reduced risk of relapse. Arthritis Res Ther. 2017 Jun 7;19(1):129. doi: 10.1186/s13075-017-1321-1.

    PMID: 28592297DERIVED

  • de Groot K, Harper L, Jayne DR, Flores Suarez LF, Gregorini G, Gross WL, Luqmani R, Pusey CD, Rasmussen N, Sinico RA, Tesar V, Vanhille P, Westman K, Savage CO; EUVAS (European Vasculitis Study Group). Pulse versus daily oral cyclophosphamide for induction of remission in antineutrophil cytoplasmic antibody-associated vasculitis: a randomized trial. Ann Intern Med. 2009 May 19;150(10):670-80. doi: 10.7326/0003-4819-150-10-200905190-00004.

    PMID: 19451574DERIVED

MeSH Terms

Conditions

Granulomatosis with PolyangiitisMicroscopic PolyangiitisVasculitis

Interventions

Cyclophosphamide

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)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Kirsten de Groot

    Klinikum Offenbach GmbH, Germany

    STUDY CHAIR

  • Caroline OS Savage

    University of Birmingham

    STUDY CHAIR

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

January 31, 2007

First Posted

February 1, 2007

Study Start

February 1, 1998

Study Completion

April 1, 2004

Last Updated

February 1, 2007

Record last verified: 2007-01