Idiopathic Retroperitoneal FibrosisPhase 3FIPREDEXNCT01240850
Methotrexate as a Steroid-sparing Agent in Idiopathic Retroperitoneal Fibrosis: a Randomised, Multicenter Trial
A Phase 3 study testing Methotrexate+Prednisone and Prednisone in people with Idiopathic Retroperitoneal Fibrosis and Perianeurysmal Retroperitoneal Fibrosis, run by University of Parma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Retroperitoneal Fibrosis, Perianeurysmal Retroperitoneal Fibrosis, Chronic Periaortitis
- What is being tested?
- Methotrexate+Prednisone and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- May 2007to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosis of idiopathic retroperitoneal fibrosis or chronic periaortitis; written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Nephrology Unit, University Hospital of Parma
Parma, Parma, 43126
Augusto Vaglio, MD PhD, +39 0521 702345, augusto.vaglio@virgilio.it
Augusto Vaglio, MD PhD
About this study
Official title: Medical Therapy in Idiopathic Retroperitoneal Fibrosis: a Multicenter, Randomized, Controlled Trial of Prednisone vs Low-dose Prednisone Plus Methotrexate
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.
- Conditions
- Idiopathic Retroperitoneal Fibrosis, Perianeurysmal Retroperitoneal Fibrosis, Chronic Periaortitis
- Being tested
- Methotrexate+Prednisone, Prednisone
- Keywords
- Retroperitoneal fibrosis, Inflammatory aneurysms, Methotrexate, Prednisone, Aorta
- Medical subject headings
- Retroperitoneal Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate+PrednisoneDrug
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
PrednisoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Active comparator | Not described Receives: Drug: Prednisone |
| Methotrexate+Prednisone | Experimental | Not described Receives: Drug: Methotrexate+Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate by the end of treatment
Secondary outcomes (3)
Reduction in size of the retroperitoneal mass on CT/MRI scans
Rate of post-treatment relapses
Treatment-related toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startMay 2007
- Primary completionMay 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Retroperitoneal FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Investigators
- Augusto Vaglio, MD, PhD, Principal investigator, Parma University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240850
- Sponsor's protocol ID
- FARM79BKPY
- Other IDs
- 2008-007353-12, 2008
- Acronym
- FIPREDEX
- Status last verified
- Nov 2010
- First submitted
- 12 Nov 2010
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17472843Vaglio 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.
PubMed 18037118Vaglio A, Salvarani C, Buzio C. Retroperitoneal fibrosis. Lancet. 2006 Jan 21;367(9506):241-51. doi: 10.1016/S0140-6736(06)68035-5.
PubMed 16427494Warnatz 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.
PubMed 15897305Peyronel 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 Dec;157:103487. doi: 10.1016/j.jaut.2025.103487. Epub 2025 Sep 19.
PubMed 40974866
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Therapy in Idiopathic Retroperitoneal Fibrosis: a Multicenter, Randomized, Controlled Trial of Prednisone vs Low-dose Prednisone Plus Methotrexate
- ClinicalTrials.gov ID
- NCT01240850
- Acronym / sponsor ID
- FIPREDEX / FARM79BKPY
- Conditions
- Idiopathic Retroperitoneal Fibrosis, Perianeurysmal Retroperitoneal Fibrosis, Chronic Periaortitis
- Keywords
- Retroperitoneal fibrosis, Inflammatory aneurysms, Methotrexate, Prednisone, Aorta
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Active comparator | Drug: Prednisone |
| Methotrexate+Prednisone | Experimental | Drug: Methotrexate+Prednisone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- New diagnosis of idiopathic retroperitoneal fibrosis or chronic periaortitis; written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Methotrexate+Prednisone |
| Prednisone | Drug | Prednisone |
Primary outcome
Remission rate by the end of treatment
3 secondary outcomes
Reduction in size of the retroperitoneal mass on CT/MRI scans
Rate of post-treatment relapses
Treatment-related toxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
- Background: PubMed 17472843van 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.
- Background: PubMed 18037118Vaglio 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.
- Background: PubMed 16427494Vaglio A, Salvarani C, Buzio C. Retroperitoneal fibrosis. Lancet. 2006 Jan 21;367(9506):241-51. doi: 10.1016/S0140-6736(06)68035-5.
- Background: PubMed 15897305Warnatz 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.
- Derived from this study: PubMed 40974866Peyronel 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 Dec;157:103487. doi: 10.1016/j.jaut.2025.103487. Epub 2025 Sep 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Augusto Vaglio, MD, PhD principal investigator
Parma University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate+Prednisone and Prednisone in people with Idiopathic Retroperitoneal Fibrosis and Perianeurysmal Retroperitoneal Fibrosis, run by University of Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Buzio, MD (+39 0521 702345, carlo.buzio@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate by the end of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240850, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2010.