Status:
UNKNOWN
Methotrexate as a Steroid-sparing Agent in Idiopathic Retroperitoneal Fibrosis: a Randomised, Multicenter Trial
Lead Sponsor:
University of Parma
Conditions:
Idiopathic Retroperitoneal Fibrosis
Perianeurysmal Retroperitoneal Fibrosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- New diagnosis of idiopathic retroperitoneal fibrosis or chronic periaortitis; written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01240850
Start Date
May 1 2007
End Date
December 1 2013
Last Update
November 15 2010
Active Locations (1)
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1
Nephrology Unit, University Hospital of Parma
Parma, Parma, Italy, 43126