Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000845831
Ethics application status
Approved
Date submitted
30/07/2012
Date registered
13/08/2012
Date last updated
13/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Methotrexate plus Prednisone in patients with relapsing
Idiopathic Retroperitoneal Fibrosis.
Scientific title
For patients affected by relapsing Idiopathic Retroperitoneal Fibrosis, will treatment with Methotrexate plus Prednisone be effective in achieving and mantaining disease remission.
Secondary ID [1] 280839 0
Nil
Universal Trial Number (UTN)
U1111-1132-6069
Trial acronym
rIRF-MTXPDN01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Idiopathic Retroperitoneal Fibrosis 286906 0
Condition category
Condition code
Inflammatory and Immune System 287226 287226 0 0
Other inflammatory or immune system disorders
Renal and Urogenital 287227 287227 0 0
Other renal and urogenital disorders
Renal and Urogenital 287357 287357 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We enrolled all relapsing idiopathic retroperitoneal fibrosis patients seen at our Department between July 2004 and April 2011. The patients received Prednisone and Methotrexate for one year.
The enrolled patients received prednisone (PDN) at a starting dose of 0.5-1 mg/Kg/day depending on relapse severity then tapered to 5 mg/day within 6-8 months and kept at a maintenance dose of 2.5-5 mg/day until month 12. The tapering schedule was left at the discretion of the treating clinician. PDN was given as oral tablets once daily for one year.
Methotrexate (MTX) was given orally (or intramuscularly if the oral administration was not tolerated) at a starting dose of 10-15 mg/week, rapidly titrated up to 15-20 mg/week; the MTX dose was kept unchanged until month 12.
Intervention code [1] 285262 0
Treatment: Drugs
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287519 0
The primary study end-point was the
remission rate at month 12, with remission being defined
as disappearance of symptoms, normalisation of erythrocyte sedimentation rate and C-reactive protein values, and absence of hydronephrosis.
Remission was assessed basing on patients symptoms, imaging assessments (CT or MR) and blood tests.
Timepoint [1] 287519 0
12 months.
Secondary outcome [1] 298309 0
change in idiopathic retroperitoneal fibrosis thickness.

This outcome was assessed basing on the measured thickness of the retrperitoneal tissue during the imaging assessments (CT or MR).
Timepoint [1] 298309 0
6 months, 12 months, end of follow-up.
Secondary outcome [2] 298310 0
variations in erythrocyte sedimentation rate and C-reactive
protein values

This outcome was assessed on blood analysis results.
Timepoint [2] 298310 0
6 months, 12 months, end of follow-up.
Secondary outcome [3] 298311 0
change in estimated glomerular filtration rates (eGFR)

This outcome was assessed on blood analysis results.
Timepoint [3] 298311 0
6 months, 12 months, end of follow-up.
Secondary outcome [4] 298312 0
presence or absence of ureteral obstruction and of ureteral decompressive device.

This outcome was assessed basing on imaging assessments (ultrasounds, CT or MR) results.
Timepoint [4] 298312 0
6 months, 12 months, end of follow-up.

Eligibility
Key inclusion criteria
Diagnosis of relapsing idiopathic retroperitoneal fibrosis and an age between 18 and 85 years.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, active infections or malignancies, known hypersensitivity to the study drugs, uncontrolled diabetes and retroperitoneal fibrosis secondary to known causes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
28/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 4403 0
Italy
State/province [1] 4403 0

Funding & Sponsors
Funding source category [1] 285628 0
Self funded/Unfunded
Name [1] 285628 0
Country [1] 285628 0
Primary sponsor type
Individual
Name
Augusto Vaglio
Address
Via Gramsci 14, 43126 Parma, Italy
Country
Italy
Secondary sponsor category [1] 284462 0
Individual
Name [1] 284462 0
Federico Alberici
Address [1] 284462 0
Via Gramsci 14, 43126 Parma, Italy
Country [1] 284462 0
Italy

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The study aims to demonstrate that the combination of an immunosuppressant (methotrexate) and a cortisonic (prednisone) is effective for patients who suffer from relapsing idiopathic retroperitoneal fibrosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34431 0
Address 34431 0
Country 34431 0
Phone 34431 0
Fax 34431 0
Email 34431 0
Contact person for public queries
Name 17678 0
Augusto Vaglio
Address 17678 0
Nefrologia, Azienda Ospedaliero-Universitaria, Via Gramsci 14, 43126 Parma
Country 17678 0
Italy
Phone 17678 0
+39 0521 033176
Fax 17678 0
+39 0521 033185
Email 17678 0
[email protected]
Contact person for scientific queries
Name 8606 0
Augusto Vaglio
Address 8606 0
Nefrologia, Azienda Ospedaliero-Universitaria, Via Gramsci 14, 43126 Parma
Country 8606 0
Italy
Phone 8606 0
+39 0521 033176
Fax 8606 0
+39 0521 033185
Email 8606 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.