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

Phase 3

• Conditions: Idiopathic Retroperitoneal Fibrosis; Perianeurysmal Retroperitoneal Fibrosis; Chronic Periaortitis
• Interventions: Drug: Prednisone; Drug: Methotrexate+Prednisone

• Registration Number: NCT01240850
• Lead Sponsor: University of Parma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Status Verified: 2010-11
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Last Update Submitted: 2010-11-12
• Study First Posted: 2010-11-15
• Last Update Posted: 2010-11-15
• Primary Completion: 2012-05
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prednisone	Prednisone	-
Methotrexate+Prednisone	Methotrexate+Prednisone	-

Primary Outcome Measures

Name	Time	Method
Remission rate by the end of treatment

Secondary Outcome Measures

Name	Time	Method
Reduction in size of the retroperitoneal mass on CT/MRI scans
Rate of post-treatment relapses
Treatment-related toxicity

Trial Locations

Locations (1)

Nephrology Unit, University Hospital of Parma; 🇮🇹 Parma, Italy