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

NCT ID: NCT01240850

Last Updated: 2010-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Idiopathic Retroperitoneal Fibrosis Perianeurysmal Retroperitoneal Fibrosis Chronic Periaortitis

Keywords

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Retroperitoneal fibrosis Inflammatory aneurysms Methotrexate Prednisone Aorta

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prednisone

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

Methotrexate+Prednisone

Group Type EXPERIMENTAL

Methotrexate+Prednisone

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Prednisone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Parma

OTHER

Sponsor Role lead

Responsible Party

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University of Parma

Principal Investigators

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Augusto Vaglio, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Parma University Hospital

Locations

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Nephrology Unit, University Hospital of Parma

Parma, Parma, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Carlo Buzio, MD

Role: CONTACT

Phone: +39 0521 702345

Email: [email protected]

Augusto Vaglio, MD, PhD

Role: CONTACT

Phone: +39 0521 702345

Email: [email protected]

Facility Contacts

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Augusto Vaglio, MD PhD

Role: primary

References

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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. doi: 10.1053/j.ajkd.2007.02.268.

Reference Type BACKGROUND
PMID: 17472843 (View on PubMed)

Vaglio A, Palmisano A, Corradi D, Salvarani C, Buzio C. Retroperitoneal fibrosis: evolving concepts. Rheum Dis Clin North Am. 2007 Nov;33(4):803-17, vi-vii. doi: 10.1016/j.rdc.2007.07.013.

Reference Type BACKGROUND
PMID: 18037118 (View on PubMed)

Vaglio A, Salvarani C, Buzio C. Retroperitoneal fibrosis. Lancet. 2006 Jan 21;367(9506):241-51. doi: 10.1016/S0140-6736(06)68035-5.

Reference Type BACKGROUND
PMID: 16427494 (View on PubMed)

Warnatz K, Keskin AG, Uhl M, Scholz C, Katzenwadel A, Vaith P, Peter HH, Walker UA. Immunosuppressive treatment of chronic periaortitis: a retrospective study of 20 patients with chronic periaortitis and a review of the literature. Ann Rheum Dis. 2005 Jun;64(6):828-33. doi: 10.1136/ard.2004.029793.

Reference Type BACKGROUND
PMID: 15897305 (View on PubMed)

Peyronel F, Palmisano A, Maritati F, Alberici F, Urban ML, Gianfreda D, Rossi GM, Fenaroli P, Bettiol A, Moroni G, Vaglio A. Methotrexate and low-dose prednisone in idiopathic retroperitoneal fibrosis: a randomised clinical trial. J Autoimmun. 2025 Sep 19;157:103487. doi: 10.1016/j.jaut.2025.103487. Online ahead of print.

Reference Type DERIVED
PMID: 40974866 (View on PubMed)

Other Identifiers

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2008-007353-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FARM79BKPY

Identifier Type: -

Identifier Source: org_study_id