Prednisone Versus Tamoxifen in Idiopathic Retroperitoneal Fibrosis

February 23, 2007 updated by: University of Parma

A Randomised Trial of Prednisone and Tamoxifen in Patients With Idiopathic Retroperitoneal Fibrosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Idiopathic retroperitoneal fibrosis (IRF) is a rare condition hallmarked by the presence of a retroperitoneal mass consisting of chronic inflammatory infiltrate and abundant fibrous tissue. IRF usually presents as a systemic inflammatory disease, with constitutional symptoms (e.g. fatigue, weight loss) and high acute-phase reactants; in addition, IRF patients often complain of abdominal or lumbar pain and, if ureteral involvement is present, they may also show oliguria and symptoms related to uremia.

Ureteral obstructive disease is usually managed by placement of ureteral indwelling stents, nephrostomy tubes or, in the more severe cases, surgical ureterolysis. These approaches are usually followed by medical treatment.

The medical treatment of IRF is largely empirical: corticosteroids are routinely used, but a number of reports have shown that tamoxifen may also be effective. However, no prospective controlled trials have been conducted in patients with this condition. In this study, we compare the efficacy of prednisone and tamoxifen in IRF patients.

Patients who received a diagnosis of IRF will be enrolled, while patients with secondary forms of retroperitoneal fibrosis (e.g. drugs, infections, radiotherapy) will be excluded. When present, ureteral obstruction will be managed by ureteral stents/nephrostomy/ureterolysis. All patients will then receive oral prednisone (1 mg/kg/day) for one month, at the end of which they will be randomized to receive either tamoxifen (0.5 mg/kg/day at fixed dose for 8 months) or prednisone (0.5 mg/kg/day for the first month, 0.25 mg/kg/day for the second and third months, and then tapered off during the ensuing 5 months). A CT/MRI study will be performed before the start of treatment, four months after randomization and at the end of treatment. All patients will be followed up for at least 18 months after the end of treatment.

Disease remission will be defined on the basis of clinical symptoms related to IRF (e.g. pain, constitutional symptoms), levels of acute-phase reactants (erythrocyte sedimentation rate, C-reactive protein), and ureteral obstruction (as assessed by sonography or CT/MRI scan).

Study Type

Interventional

Enrollment

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43100
        • Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of idiopathic or perianeurismal retroperitoneal fibrosis

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Difference in recurrence rate at the end of treatment

Secondary Outcome Measures

Outcome Measure
Difference in reduction in size of IRF (as assessed by CT/MRI)
Difference in renal function

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Parma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Study Completion

April 1, 2007

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 23, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

February 27, 2007

Last Update Submitted That Met QC Criteria

February 23, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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