Methotrexate as a Steroid-sparing Agent in Idiopathic Retroperitoneal Fibrosis: a Randomised, Multicenter Trial (FIPREDEX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01240850|
Recruitment Status : Unknown
Verified November 2010 by University of Parma.
Recruitment status was: Recruiting
First Posted : November 15, 2010
Last Update Posted : November 15, 2010
Chronic periaortitis is a clinico-pathological entity encompassing idiopathic retroperitoneal fibrosis and perianeurysmal retroperitoneal fibrosis. The treatment of this disease is generally based on the use of glucocorticoids, which are often effective. However, prolonged steroid treatments are usually needed to achieve a sustained remission; additionally, patients frequently develop disease relapses following treatment discontinuation, therefore they may be exposed to high cumulative doses of glucocorticoids.
Preliminary data reported in the literature show that methotrexate may be effective in combination with prednisone for retroperitoneal fibrosis. In addition, methotrexate is often used as a steroid-sparing agent in different inflammatory diseases.
The aim of this study is to evaluate whether a treatment with low-dose prednisone plus methotrexate is non-inferior to conventional dose-prednisone in achieving remission in retroperitoneal fibrosis patients.
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Retroperitoneal Fibrosis Perianeurysmal Retroperitoneal Fibrosis Chronic Periaortitis||Drug: Methotrexate+Prednisone Drug: Prednisone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Masking:||None (Open Label)|
|Official Title:||Medical Therapy in Idiopathic Retroperitoneal Fibrosis: a Multicenter, Randomized, Controlled Trial of Prednisone vs Low-dose Prednisone Plus Methotrexate|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||December 2013|
U.S. FDA Resources
|Active Comparator: Prednisone||Drug: Prednisone|
Methotrexate will be added at a dose of 0.3 mg/kg/week (maximum dose, 20 mg/week, orally) to a reduced-dose prednisone regimen
- Remission rate by the end of treatment
- Reduction in size of the retroperitoneal mass on CT/MRI scans
- Rate of post-treatment relapses
- Treatment-related toxicity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240850
|Contact: Carlo Buzio, MD||+39 0521 firstname.lastname@example.org|
|Contact: Augusto Vaglio, MD, PhD||+39 0521 email@example.com|
|Nephrology Unit, University Hospital of Parma||Recruiting|
|Parma, Italy, 43126|
|Contact: Augusto Vaglio, MD PhD +39 0521 702345 firstname.lastname@example.org|
|Principal Investigator: Augusto Vaglio, MD PhD|
|Principal Investigator:||Augusto Vaglio, MD, PhD||University Hospitals Parma Medical Center|