CellCept in p-ANCA Vasculitis

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00405860
First received: November 29, 2006
Last updated: March 21, 2011
Last verified: March 2011

November 29, 2006
March 21, 2011
December 2002
July 2008   (final data collection date for primary outcome measure)
The primary endpoint is successful induction of remission as defined in Appendix 6 within 6 months.
Same as current
Complete list of historical versions of study NCT00405860 on ClinicalTrials.gov Archive Site
  • Major relapse necessitating a switch to induction OCS/CYC treatment or more aggressive treatment (e.g. plasma exchange).
  • Minor relapses that can effectively be controlled by a transient, non-toxic increase in OCS
  • Intolerance to trial medications and adverse effects. Adverse effects will be monitored
Same as current
Not Provided
Not Provided
 
CellCept in p-ANCA Vasculitis
A Pilot Study of Mycophenolate Mofetil (MMF) in Patients With p-ANCA Microscopic Polyangiitis and Mild to Moderate Renal Dysfunction.

Microscopic polyangiitis (MP) is a primary systemic vasculitis predominantly affecting small blood vessels. Following the widespread introduction of ANCA testing, the primary systemic vasculitis (SV), Wegener?s granulomatosis (WG) and microscopic polyangiitis (MP) appear to be more frequent than was previously thought (see definitions in Appendix 6). In addition, the existence of early and organ-limited forms of these diseases, such as renal-limited vasculitis (RLV) is now clearly recognized. Their annual incidence exceeds 20 per million per year and they account for at least 5 % of the causes of end stage renal failure. The two diseases share many features of their histology, serology and response to treatment, pointing to similarities in their pathogenesis, which have justified a common approach to their management. The standard treatment with corticosteroids (CS) and cyclophosphamide (CYC) is usually effective at controlling active disease but continued treatment is necessary to prevent disease relapse. Due to the cumulative toxicity associated with CYC treatment, alternatives have been looked for. Mycophenolate mofetil (MMF) has been used to treat patients with a variety of immune-mediated nephritides, including ANCA-associated vasculitis, with less toxicity than CYC but with variable outcome. The present trial will examine whether substitution of oral CYC with oral MMF is equally efficient for induction of remission with less adverse effects in cases of MP with mild to moderate renal involvement. All patients will receive the same regimen of oral prednisone + MMF. Prednisone will be tapered to a stop after 24 weeks but MMF will continue for a total of 18 months unless there is worsening or persistent disease. The trial ends after 18 months.

  1. Patients will receive I.V. methylprednisone, or I.V. dexamethazone, oral prednisone and oral MMF therapy as outlined in table 2.
  2. MMF will be initiated within the first 1-2 weeks of the start of steroids. Patients will receive CellCept, 750 mg po b.i.d for the first week. Dose will be increased to 1000 mg po b.i.d for the second week, and thereafter, according to blood levels and patient tolerance. Target blood levels are 1 ? 3.5 g/ml. Treatment will be for a total of 18 months. This is based on the published dose-dependent adverse effect profiles in transplant patients (31-32) and on reports that lower doses are ineffective and shorter courses (less then 6 months) result in relapses or failure of therapy (25). Dose will be reduced in patient who can not tolerate MMF at the above dose.

2) Relapse treatment to follow guidelines for relapse regimens. 3) After 18 months, all medications will be tapered to a full stop unless disease is active or grumbling.

4) Pneumocystis pneumonia prophylaxis will be used during the trial (with sulfamethoxazole/trimethoprim, or Dapsone or Mepron if allergic to sulfa).

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • MPO-ANCA Vasculitis
  • Microscopic Polyangiitis
Drug: CellCept (mycophenolate mofetil)
Not Provided
Silva F, Specks U, Kalra S, Hogan MC, Leung N, Sethi S, Fervenza FC. Mycophenolate mofetil for induction and maintenance of remission in microscopic polyangiitis with mild to moderate renal involvement--a prospective, open-label pilot trial. Clin J Am Soc Nephrol. 2010 Mar;5(3):445-53. doi: 10.2215/CJN.06010809. Epub 2010 Jan 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2008
July 2008   (final data collection date for primary outcome measure)
  1. Active microscopic polyangiitis
  2. Active urinary sediment (>25 rbc/hpf, red cell casts or dysmorphic red cells)
  3. Renal biopsy compatible with the diagnosis of microscopic polyangiitis, or diagnosis demonstrated by the presence of hematuria, proteinuria, and dysmorphic red blood cells, and / or red blood casts when biopsy is contraindicated.
  4. Positive p-ANCA (MPO ELISA)
  5. Serum creatinine < 3.0mg/dl.
  6. Age 18 years or over.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00405860
1679-02
Not Provided
Not Provided
Mayo Clinic
Roche Pharma AG
Principal Investigator: Fernando C. Fervenza, M.D., Ph.D. Mayo Clinic
Mayo Clinic
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP