NCT00440349

Brief Summary

Idiopathic retroperitoneal fibrosis (IRF) is a rare disease characterised by the presence of a retroperitoneal periaortic fibro-inflammatory tissue which may entrap the ureters and cause renal failure. The treatment of IRF is not well established. Corticosteroids are frequently used, but the anti-estrogen agent tamoxifen has also been reported to be effective in a number of reports. However, no randomised trials have been published so far. The aim of the present study is to compare the efficacy of prednisone and tamoxifen in the treatment of IRF.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

February 27, 2007

Status Verified

February 1, 2007

First QC Date

February 23, 2007

Last Update Submit

February 23, 2007

Conditions

Retroperitoneal Fibrosis

Keywords

Retroperitoneal fibrosisTamoxifenCorticosteroidsObstructive uropathyPeriaortic fibrosisChronic periaortitis

Outcome Measures

Primary Outcomes (1)

  • Difference in recurrence rate at the end of treatment

Secondary Outcomes (2)

  • Difference in reduction in size of IRF (as assessed by CT/MRI)

  • Difference in renal function

Interventions

TamoxifenDRUG
PrednisoneDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of idiopathic or perianeurismal retroperitoneal fibrosis

You may not qualify if:

  • Previously treated patients; retroperitoneal fibrosis secondary to drugs(e.g. methysergide, methyldopa, pergolide, ergot alkaloids), infections (e.g. tuberculosis), cancer (e.g. lymphoma, sarcoma), radiotherapy, trauma, major surgery, systemic connective tissue or vasculitis disease (e.g. SLE, panarteritis nodosa); pregnancy; active infections or tumours; known hypersensitivity to prednisone or tamoxifen; uncontrolled diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital

Parma, Parma, 43100, Italy

Location

Related Publications (6)

  • van Bommel EF, Hendriksz TR, Huiskes AW, Zeegers AG. Brief communication: tamoxifen therapy for nonmalignant retroperitoneal fibrosis. Ann Intern Med. 2006 Jan 17;144(2):101-6. doi: 10.7326/0003-4819-144-2-200601170-00007.

    PMID: 16418409BACKGROUND

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

    PMID: 16427494BACKGROUND

  • Vaglio A, Buzio C. Chronic periaortitis: a spectrum of diseases. Curr Opin Rheumatol. 2005 Jan;17(1):34-40. doi: 10.1097/01.bor.0000145517.83972.40.

    PMID: 15604902BACKGROUND

  • Kardar AH, Kattan S, Lindstedt E, Hanash K. Steroid therapy for idiopathic retroperitoneal fibrosis: dose and duration. J Urol. 2002 Aug;168(2):550-5.

    PMID: 12131307BACKGROUND

  • Moroni G, Gallelli B, Banfi G, Sandri S, Messa P, Ponticelli C. Long-term outcome of idiopathic retroperitoneal fibrosis treated with surgical and/or medical approaches. Nephrol Dial Transplant. 2006 Sep;21(9):2485-90. doi: 10.1093/ndt/gfl228. Epub 2006 May 15.

    PMID: 16702201BACKGROUND

  • Vaglio A, Palmisano A, Alberici F, Maggiore U, Ferretti S, Cobelli R, Ferrozzi F, Corradi D, Salvarani C, Buzio C. Prednisone versus tamoxifen in patients with idiopathic retroperitoneal fibrosis: an open-label randomised controlled trial. Lancet. 2011 Jul 23;378(9788):338-46. doi: 10.1016/S0140-6736(11)60934-3. Epub 2011 Jul 4.

    PMID: 21733570DERIVED

MeSH Terms

Conditions

Retroperitoneal Fibrosis

Interventions

TamoxifenPrednisone

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Carlo Buzio, MD

    University of Parma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 27, 2007

Study Start

October 1, 2000

Study Completion

April 1, 2007

Last Updated

February 27, 2007

Record last verified: 2007-02

Locations

IT(1)