Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103792
Status:
COMPLETED
Last Update Posted:
2009-02-16
First Post:
2005-02-14
Brief Title:
Mycophenolate Mofetil for Treatment of Relapses of Wegeners Disease or Microscopic Polyangiitis MPA
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Comparative Study of the Efficacy of Induction Therapy With Cyclophosphamide or Mycophenolate Mofetil for Non-life-threatening Relapses of PR3- or MPO-ANCA Associated Vasculitis
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the efficacy and safety of a new drug mycophenolate mofetil for the treatment of relapses of ANCA-associated vasculitis Wegeners granulomatosis or microscopic polyangiitis Therefore we compare the standard therapy with cyclophosphamide to mycophenolate mofetil
The investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide
The investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide
Detailed Description:
Treatment of ANCA-associated vasculitis consists of two phases remission induction with highly effective but also relatively toxic drugs and secondly after remission is achieved maintenance therapy with less toxic drugs The standard induction therapy of a relapse of Wegeners granulomatosis or microscopic polyangiitis consists of the combination of cyclophosphamide and prednisolone Although this induction therapy is very effective it is very toxic as well
Searching for an alternative for cyclophosphamide we will test the efficacy and safety of a new combination therapy with mycophenolate mofetil and prednisolone We will compare the effect and safety of the standard induction therapy with the new therapy When relapses occur patients will be randomized for either the standard therapy with cyclophosphamide or for mycophenolate mofetil
Searching for an alternative for cyclophosphamide we will test the efficacy and safety of a new combination therapy with mycophenolate mofetil and prednisolone We will compare the effect and safety of the standard induction therapy with the new therapy When relapses occur patients will be randomized for either the standard therapy with cyclophosphamide or for mycophenolate mofetil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMCG-ANCA-MMF-1 | None | None | None |