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

Idiopathic Retroperitoneal Fibrosis Clinical Trial

— FIPREDEX  

Official title:

Medical Therapy in Idiopathic Retroperitoneal Fibrosis: a Multicenter, Randomized, Controlled Trial of Prednisone vs Low-dose Prednisone Plus Methotrexate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01240850
• Other study ID #: FARM79BKPY
• Secondary ID: 2008-007353-12
• Status: Recruiting
• Phase: Phase 3
• First received: November 12, 2010
• Last updated: November 12, 2010
• Start date: May 2007
• Est. completion date: December 2013

Study information

• Verified date: November 2010
• Source: University of Parma
• Contact: Carlo Buzio, MD
• Phone: +39 0521 702345
• Email: carlo.buzio[@]unipr.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periaortitis
• Fibrosis
• Idiopathic Retroperitoneal Fibrosis
• Perianeurysmal Retroperitoneal Fibrosis
• Retroperitoneal Fibrosis

Intervention

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
• Prednisone

Locations

Country	Name	City	State
Italy	Nephrology Unit, University Hospital of Parma	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Vaglio A, Palmisano A, Corradi D, Salvarani C, Buzio C. Retroperitoneal fibrosis: evolving concepts. Rheum Dis Clin North Am. 2007 Nov;33(4):803-17, vi-vii. Review. — View Citation

Vaglio A, Salvarani C, Buzio C. Retroperitoneal fibrosis. Lancet. 2006 Jan 21;367(9506):241-51. Review. — View Citation

van Bommel EF, Siemes C, Hak LE, van der Veer SJ, Hendriksz TR. Long-term renal and patient outcome in idiopathic retroperitoneal fibrosis treated with prednisone. Am J Kidney Dis. 2007 May;49(5):615-25. — View Citation

Warnatz K, Keskin AG, Uhl M, Scholz C, Katzenwadel A, Vaith P, Peter HH, Walker UA. Immunosuppressive treatment of chronic periaortitis: a retrospective study of 20 patients with chronic periaortitis and a review of the literature. Ann Rheum Dis. 2005 Jun;64(6):828-33. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate by the end of treatment			No
Secondary	Reduction in size of the retroperitoneal mass on CT/MRI scans			No
Secondary	Rate of post-treatment relapses			No
Secondary	Treatment-related toxicity			Yes