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

Idiopathic Retroperitoneal Fibrosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Idiopathic Retroperitoneal Fibrosis

Perianeurysmal Retroperitoneal Fibrosis

Chronic Periaortitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Methotrexate+PrednisoneMethotrexate 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Prednisone

Methotrexate+Prednisone

Study Status

Unknown status

Start Date: May 2007

Completed Date: December 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Remission rate by the end of treatment

Secondary Outcome: Reduction in size of the retroperitoneal mass on CT/MRI scans

Study sponsors, principal investigator, and references

Principal Investigator: Augusto Vaglio, MD, PhD

Lead Sponsor: University of Parma

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01240850

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.

Discuss Prednisone