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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
  Purpose

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 Intervention Phase
Idiopathic Retroperitoneal Fibrosis
Perianeurysmal Retroperitoneal Fibrosis
Chronic Periaortitis
 Drug: Methotrexate+Prednisone
Drug: Prednisone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by University of Parma:

Primary Outcome Measures:
  • Remission rate by the end of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: May 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240850

Contacts
Contact: Carlo Buzio, MD +39 0521 702345 carlo.buzio@unipr.it
Contact: Augusto Vaglio, MD, PhD +39 0521 702345 augusto.vaglio@virgilio.it

Locations
Italy
Nephrology Unit, University Hospital of Parma Recruiting
Parma, Italy, 43126
Contact: Augusto Vaglio, MD PhD     +39 0521 702345     augusto.vaglio@virgilio.it    
Principal Investigator: Augusto Vaglio, MD PhD            
Sponsors and Collaborators
University of Parma
Investigators
Principal Investigator: Augusto Vaglio, MD, PhD University Hospital of Parma
  More Information

Publications:

Responsible Party: Prof Carlo Buzio, University of Parma
ClinicalTrials.gov Identifier: NCT01240850     History of Changes
Other Study ID Numbers: FARM79BKPY, 2008−007353−12
Study First Received: November 12, 2010
Last Updated: November 12, 2010
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of Parma:
Retroperitoneal fibrosis
Inflammatory aneurysms
Methotrexate
Prednisone
Aorta

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

ClinicalTrials.gov processed this record on June 18, 2013