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Methotrexate as a Steroid-sparing Agent in Idiopathic Retroperitoneal Fibrosis: a Randomised, Multicenter Trial (FIPREDEX)

This study is currently recruiting participants.
Verified November 2010 by University of Parma
Sponsor:
Information provided by:
University of Parma
ClinicalTrials.gov Identifier:
NCT01240850
First received: November 12, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 12, 2010
November 12, 2010
May 2007
May 2012   (final data collection date for primary outcome measure)
Remission rate by the end of treatment [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Reduction in size of the retroperitoneal mass on CT/MRI scans [ Designated as safety issue: No ]
  • Rate of post-treatment relapses [ Designated as safety issue: No ]
  • Treatment-related toxicity [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Methotrexate as a Steroid-sparing Agent in Idiopathic Retroperitoneal Fibrosis: a Randomised, Multicenter Trial
Medical Therapy in Idiopathic Retroperitoneal Fibrosis: a Multicenter, Randomized, Controlled Trial of Prednisone vs Low-dose Prednisone Plus Methotrexate

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
  • Idiopathic Retroperitoneal Fibrosis
  • Perianeurysmal Retroperitoneal Fibrosis
  • Chronic Periaortitis
  • Drug: Methotrexate+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
  • Drug: Prednisone
  • Active Comparator: Prednisone
    Intervention: Drug: Prednisone
  • Experimental: Methotrexate+Prednisone
    Intervention: Drug: Methotrexate+Prednisone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2013
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • New diagnosis of idiopathic retroperitoneal fibrosis or chronic periaortitis; written informed consent

Exclusion Criteria:

  • Secondary forms of retroperitoneal fibrosis (e.g. drugs, surgery, neoplasms, infections)
  • Previous medical therapy for retroperitoneal fibrosis
  • Renal failure with creatinine >2 mg/dl which proved not to be reversible after ureteral decompression
  • Hypersensitivity to the study drugs
  • Pregnancy
  • Active infections or malignant neoplasms
Both
18 Years to 80 Years
No
Contact: Carlo Buzio, MD +39 0521 702345 carlo.buzio@unipr.it
Contact: Augusto Vaglio, MD, PhD +39 0521 702345 augusto.vaglio@virgilio.it
Italy
 
NCT01240850
FARM79BKPY, 2008−007353−12
No
Prof Carlo Buzio, University of Parma
University of Parma
Not Provided
Principal Investigator: Augusto Vaglio, MD, PhD University Hospital of Parma
University of Parma
November 2010

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