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. 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
Information provided by:
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.

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
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Active Comparator: Prednisone Drug: Prednisone
Experimental: Methotrexate+Prednisone 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

Primary Outcome Measures :
  1. Remission rate by the end of treatment

Secondary Outcome Measures :
  1. Reduction in size of the retroperitoneal mass on CT/MRI scans
  2. Rate of post-treatment relapses
  3. Treatment-related toxicity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01240850

Contact: Carlo Buzio, MD +39 0521 702345
Contact: Augusto Vaglio, MD, PhD +39 0521 702345

Nephrology Unit, University Hospital of Parma Recruiting
Parma, Italy, 43126
Contact: Augusto Vaglio, MD PhD    +39 0521 702345   
Principal Investigator: Augusto Vaglio, MD PhD         
Sponsors and Collaborators
University of Parma
Principal Investigator: Augusto Vaglio, MD, PhD University Hospitals Parma Medical Center

Responsible Party: Prof Carlo Buzio, University of Parma Identifier: NCT01240850     History of Changes
Other Study ID Numbers: FARM79BKPY
2008−007353−12 ( EudraCT Number )
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: November 15, 2010
Last Verified: November 2010

Keywords provided by University of Parma:
Retroperitoneal fibrosis
Inflammatory aneurysms

Additional relevant MeSH terms:
Retroperitoneal Fibrosis
Pathologic Processes
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal